Infant, NewbornPhase 3NCT01353313
Hydrocortisone for BPD
A Phase 3 study testing Hydrocortisone in people with Infant, Newborn and Infant, Small for Gestational Age, run by NICHD Neonatal Research Network at 20 sites in United States.
Trial summary
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. Read more about this study
- Who is it for?
- Ages Up to 30 weeks
- Conditions the study is for
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight
- What is being tested?
- Hydrocortisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 20 sitesUnited States
- Study dates
- 11 Aug 2011to 12 Sep 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants <30 weeks estimated gestational age
- inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age
- have received at least 7days of mechanical ventilation;
- are receiving mechanical ventilation through an endotracheal tube .
Who cannot join
- Major congenital anomalies
- Decision to limit support
- Indomethacin or ibuprofen treatment within 48 hours of study drug
- Previous corticosteroid treatment for BPD
- Received hydrocortisone for 14 or more cumulative days
- Received hydrocortisone within 7 days of study entry
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
RTI International
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of California - Los Angeles
Los Angeles, California, 90025
Stanford University
Palo Alto, California, 94304
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, 19104
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
University of Rochester
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84108
About this study
Official title: A Randomized Controlled Trial of the Effect of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22 - 26 Months of Age in Intubated Infants < 30 Weeks Gestation Age
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.
Read the detailed description
Bronchopulmonary dysplasia (BPD) remains a leading morbidity of the extremely preterm infant, and prolonged mechanical ventilation is associated with increased risk for BPD. Dexamethasone has been used previously to facilitate extubation and decrease the incidence of BPD; however, due to adverse effects on neurodevelopmental outcomes, the use of this drug has decreased. One cohort study suggests that hydrocortisone (HC) may facilitate extubation. HC has thus far not been associated with adverse neurodevelopmental outcomes in either cohort studies or randomized controlled trials. A recent meta-analysis of postnatal corticosteroid therapy begun after the first week of life suggested that "late therapy may reduce neonatal mortality without significantly increasing the risk of adverse long-term neurodevelopmental outcomes," although the methodological quality of some of the follow-up was acknowledged to be limited.
This is a randomized controlled trial to study the efficacy and safety of a 10-day tapering course of hydrocortisone treatment for infants <30 weeks estimated gestational age at birth who remain intubated at 14 - 28 days postnatal age. Based on previous Network data these criteria define a population with a risk of death or BPD at 36 weeks postmenstrual age of approximately 65 - 75%. The primary outcome for this study will incorporate both (1) survival without moderate to severe BPD by Network physiologic definition and (2) survival without moderate or severe NDI at 18 - 22 months corrected age. Therefore, the results of this study will be reported only when follow-up data are available unless (1) the trial is stopped early by the DSMC because of strong evidence of benefit or harm, or (2) at the time all subjects have completed treatment the DCC finds a substantial survival benefit favoring hydrocortisone (p<0.001). Individual study assignment will remain masked until the follow-up is completed. Secondary outcomes will include short term measures such as respiratory morbidities and growth at 36 weeks postmenstrual age and long term measures including growth and other outcomes at 22 - 26 months corrected age.
Secondary studies include:
- Effect of Hydrocortisone on the Cardiac mass of Premature Intubated Infants - will determine left ventricular mass index at 36 weeks postmenstrual age (or prior to discharge/transfer if after 34 weeks) in infants enrolled in the hydrocortisone for BPD RCT, and compare HC-treated infants to placebo-treated infants. It will similarly assess and compare the incidence of pulmonary hypertension in these patients.
- Extended follow-up: Subjects will be seen for a follow-up visit at 5-6 years corrected age to assess functional developmental and respiratory outcomes at early school age. In a subset of five Neonatal Research Network Clinical Centers, impulse oscillometry (IOS), which is the optimal direct measure of lung capacity and function, will be performed to validate the 6-minute walk test and International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire as functional measures of pulmonary status. Also at these five Centers, the six minute walk test, ISAAAC questionnaire, and IOS will be administered as part of (1) the Healthy Lungs sub-study, which will recruit 120 TOP 5 study participants who had minimal lung disease when they were infants to define normative ranges in healthy, preterm-born children, and (2) the Healthy Lungs Two sub-study, which will recruit 120 healthy, term-born children without history of lung disease to characterize functional and mechanical respiratory outcomes at 5-7 years of age.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature, Bronchopulmonary Dysplasia
- Being tested
- Hydrocortisone, Placebo
- Keywords
- NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Intubation, Neurodevelopmental impairment
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows:
4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then
1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days
PlaceboDrug
Saline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows:
4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then
1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline placebo Receives: Drug: Placebo |
| Hydrocortisone | Experimental | hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents) Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD)
Survival without moderate or severe physiologic BPD at 36 weeks postmenstrual age. Moderate or severe physiologic BPD is defined as a requirement for supplemental oxygen and/or positive airway pressure to maintain oxygen saturation greater than 90 percent. A room air challenge was performed for infants estimated to be receiving less than 0.30 FiO2 by nasal cannula.
Measured: From day of randomization to 36 weeks post menstrual age
Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI)
Survival without moderate or severe neurodevelopmental impairment (NDI) at 22-26 months corrected age. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction from less than 20 to 200), or bilateral hearing impairment with or without amplification (by report).
Measured: From day of randomization to 22-26 months corrected age
Secondary outcomes (38)
Number of Participants With Successful Extubation
Successful extubation during the intervention period, defined as remaining extubated for greater than or equal to 1 week, including greater than or equal to 3 days after the last dose of study medication. An extubation attempt was required after 72 hours of study drug and 24 hours after meeting the following: FiO2 less than 0.40 to maintain a saturation of greater than or equal to 88 percent, mean airway pressure less than 8 cm H2O, and hemodynamically stable in the opinion of the clinical team.
Measured: From day of randomization to day 14 post randomization
Total Deaths Before Discharge
Infant died before discharge home.
Measured: From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age
BPD grade at 36 weeks postmenstrual age. BPD grades are defined as: 1. No support/room air; 2. Nasal cannula (NC) O2 less than or equal to 2L; 3. NC O2 greater than 2L or CPAP/NIPPV; 4. Invasive PPV
Measured: At 36 weeks postmenstrual age
Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA)
Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator)
Measured: From birth to 36 weeks postmenstrual age
Duration of Oxygen Supplementation up to Status
Number of days of oxygen supplementation from birth to discharge home
Measured: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Length of Hospital Stay in Days Among Survivors to Discharge
Number of days infant stayed in hospitals, among those who survived to discharge
Measured: From birth up to one year
Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA)
Infant received dexamethasone anytime before 36 weeks postmenstrual age.
Measured: From birth to 36 weeks postmenstrual age
Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI
Severity of neurodevelopmental impairment, defined as one or more of: Bayley Scales of Infant Development-III (Bayley-III) cognitive score <85 (standardized mean 100, SD 15, range 55-145), Bayley-III motor score <85 (standardized mean 100, range 45-155), Gross Motor Function Classification System (GMFCS) level ≥2, severe vision impairment in both eyes (consistent with refraction <20-200), or bilateral hearing impairment with or without amplification (by report).
Bayley-III = Bayley Scales of Infant Development III (Cognitive score standardized mean 100, SD 15, range 55-145 motor score standardized mean 100, range 45-155; higher score indicates better performance (20))
Measured: At 22-26 months corrected age
Number of Participants With Gross Motor Function Greater Than or Equal to Level 2
Number of infants with Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment)
Measured: At 22-26 months corrected age
Number of Participants With Moderate-severe Cerebral Palsy
Number of infants with moderate or severe grade of cerebral palsy. Cerebral Palsy was diagnosed when there were definite abnormalities observed in the neuromotor exam, and functional challenges as classified by GMFCS level, and classified as moderate if GMFCS level was II or III and severe if level IV or V (40).
Measured: At 22-26 months corrected age
Number of Participants With Severe Hearing Impairment (by Report)
Number of infants with bilateral hearing impairment with or without amplification (by report)
Measured: At 22-26 months corrected age
Number of Participants With no/Some Functional Vision
Number of infants with severe vision impairment in both eyes (consistent with refraction less than 20-200)
Measured: At 22-26 months corrected age
Weight Growth Measure Following Extremely Preterm Birth
This is measured as the weight Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average weight, and negative scores denote less than average weight.
Measured: At 36 weeks post-menstrual age
Follow-up Weight Growth Measure Following Extremely Preterm Birth
This is measured as the weight Z-score at 22-26 months corrected age. The Z-score is determined using the WHO weight-for-age chart, and is derived from a standardized normal distribution, where 0 designates average weight-for-age, and negative scores denote less than average weight-for-age.
Measured: At 22-26 months corrected age
Length Growth Measure Following Extremely Preterm Birth
This is measured as the length Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average length, and negative scores denote less than average length.
Measured: At 36 weeks post-menstrual age
Follow-up Length Growth Measure Following Extremely Preterm Birth
This is measured as the length Z-score at 22-26 months corrected age. The Z-score is determined using the WHO length-for-age chart, and is derived from a standardized normal distribution, where 0 designates average length-for-age, and negative scores denote less than average length-for-age.
Measured: At 22-26 months corrected age
Head Circumference Growth Measure Following Extremely Preterm Birth
This is measured as the head circumference Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average head circumference, and negative scores denote less than average head circumference.
Measured: At 36 weeks post-menstrual age
Follow-up Head Circumference Growth Measure Following Extremely Preterm Birth
This is measured as the head circumference Z-score at 22-26 months corrected age. The Z-score is determined using the WHO head circumference-for-age chart, and is derived from a standardized normal distribution, where 0 designates average head circumference-for-age, and negative scores denote less than average head circumference-for-age.
Measured: At 22-26 months corrected age
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade 40 Weeks Postmenstrual Age
BPD grade at 40 weeks postmenstrual age. BPD grades are defined as: 1. No support/room air; 2. Nasal cannula (NC) O2 less than or equal to 2L; 3. NC O2 greater than 2L or CPAP/NIPPV; 4. Invasive PPV
Measured: At 40 weeks post menstrual age
Days of Mechanical Ventilation up to Status
Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator) up to status
Measured: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Duration of Oxygen Supplementation Among Survivors to 36 Weeks
Number of days of oxygen supplementation from birth to 36 weeks post menstrual age
Measured: From birth to 36 weeks postmenstrual age
Duration of Invasive Positive Pressure Ventilation (PPV) After Postnatal Day 14
Number of days on invasive PPV after postnatal day 14
Measured: From postnatal day 15 to 36 weeks post menstrual age or Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Duration of Non-invasive Positive Pressure Ventilation (PPV) (Nasal IPPV/CPAP) After Postnatal Day 14
Number of days of non-invasive PPV after postnatal day 14
Measured: From postnatal day 15 to 36 weeks post menstrual age or Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants Who Received Inhaled Glucocorticoids During Study Period
Number of infants who received Inhaled glucocorticoids during the study intervention period
Measured: From randomization to day 14 post randomization
Number of Participants Who Received Other Systemic Glucocorticoids During Study Period
Number of infants who received other systemic glucocorticoids during the study intervention period
Measured: From randomization to day 14 post randomization
Number of Days Dexamethasone Given Before 36 Weeks PMA
Number of days infant received dexamethasone anytime before 36 weeks postmenstrual age.
Measured: From birth to 36 weeks postmenstrual age
Number of Participants With Patent Ductus Arteriosus (PDA) Treated With Medication or Surgery
Number of infants with a Patent Ductus Arteriosus (PDA) that was treated with medicine or surgery
Measured: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants Diagnosed With Necrotizing Enterocolitis (NEC)
Number of infants diagnosed with Necrotizing Enterocolitis (NEC)
Measured: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Retinopathy of Prematurity (ROP) Stage 3 or Worse
Number of infants diagnosed with ROP stage 3 or worse in either eye. ROP stage 3 or worse is determined based on the extent of extraretinal fibrovascular proliferation. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.
Measured: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants Receiving Therapy for Retinopathy of Prematurity (ROP)
Number of infants receiving therapy for Retinopathy of prematurity (ROP)
Measured: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Severe Intraventricular Hemorrhage (IVH)
Number of infants with severe IVH, grade 3 or 4. Severity of IVH is hierarchical. Grade 3 occurs when the ventricular size is enlarged and blood/echodensity is in the ventricle. Grade 4 occurs when blood/echodensity is in the parenchyma.
Measured: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Periventricular Leukomalacia
Number of infants with Periventricular leukomalacia
Measured: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Neurodevelopmental Impairment (NDI)
Number of infants with NDI. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction less than 20-200), or bilateral hearing impairment with or without amplification (by report).
Measured: At 22-26 months corrected age
Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 85
Number of infants with a BSID-III cognitive composite score less than 85. (standardized mean 100, SD 15, range 55-145). Higher scores indicate better performance. Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.
Measured: At 22-26 months corrected age
Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 70
Number of infants with a BSID-III cognitive composite score less than 70. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.
Measured: At 22-26 months corrected age
Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 85
Number of infants with a BSID-III motor composite score less than 85. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.
Measured: At 22-26 months corrected age
Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 70
Number of infants with a BSID-III motor composite score less than 70. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.
Measured: At 22-26 months corrected age
Number of Participants With Any Cerebral Palsy
Number of infants with cerebral palsy. Cerebral Palsy was diagnosed when there were definite abnormalities observed in the neuromotor exam, and functional challenges as classified by GMFCS level, and classified as moderate if GMFCS level was II or III and severe if level IV or V (40).
Measured: At 22-26 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study start11 Aug 2011
- Primary completion21 Sep 2020
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Michele C Walsh, MD, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's HospitalSeetha Shankaran, MD, Principal investigator, Wayne State UniversityAbbot R Laptook, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandC. Michael Cotten, MD, Principal investigator, Duke UniversityDavid Carlton, MD, Principal investigator, Emory UniversityGreg Sokol, MD, Principal investigator, Indiana UniversityAbhik Das, PhD, Principal investigator, RTI InternationalKrisa P Van Meurs, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353313
- Sponsor's protocol ID
- NICHD-NRN-0045
- Other IDs
- U10HD034216, U10HD027904, U10HD021364, U10HD027853, U10HD040689, U10HD040492, U10HD027851, U10HD021373
- Status last verified
- Feb 2025
- First submitted
- 20 Apr 2011
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov)
Publications
DeMauro SB, Kirpalani H, Hintz S, Watterberg KL, Watson V, Lowe J, Shankaran S, Chawla S, Vohr B, Msall ME, D'Angio CT, Yoder BA, Lai K, Winter S, Colaizy TT, Merhar SL, Ziolkowski K, Bann CM, Trotta M, Newman JE, Walsh MC, Higgins RD, Cahill TE, Duncan AF, Wilson-Costello DE, Peralta-Carcelen M, Arnold H, Mosquera RA, Heyne RJ, Fuller J, McGowan EC, Cavanaugh B, Harmon HM, Maitre NL, Neel ML, Van Meurs KP, Richards LA, Kilbride HW, Hines AC, Natarajan G, Trembath A, Benninger KL, Kesavan K, Malcolm WF, Zanger D, Reynolds AM, Carlson M, Das A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Hydrocortisone in Preterm Infants and School-Age Functional Outcomes: Follow-Up of a Randomized Clinical Trial. JAMA Pediatr. 2026 Feb 1;180(2):134-143. doi: 10.1001/jamapediatrics.2025.4801.
PubMed 41359352Sankar MN, Chock V, Myers F, Davis AS, McDonald S, Rysavy MA, Laughon M, Bhombal S, Van Meurs KP, Das A, Benitz WE, Watterberg K; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Patent Ductus Arteriosus, Hydrocortisone, and Outcome among Infants Born Extremely Preterm: Secondary Analysis of the Hydrocortisone Trial. J Pediatr. 2025 Jun;281:114535. doi: 10.1016/j.jpeds.2025.114535. Epub 2025 Mar 14.
PubMed 40090543DeMauro SB, Kirpalani H, Ziolkowski K, Hintz S, Watterberg K, Lowe J, Shankaran S, Chawla S, Vohr B, Msall M, D'Angio C, Yoder BA, Lai K, Winter S, Colaizy T, Merhar S, Bann CM, Trotta M, Newman J, Natarajan A, Das A. The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for a longitudinal cohort study. BMC Pediatr. 2024 Nov 14;24(1):737. doi: 10.1186/s12887-024-05198-9.
PubMed 39543521Gentle SJ, Rysavy MA, Li L, Laughon MM, Patel RM, Jensen EA, Hintz S, Ambalavanan N, Carlo WA, Watterberg K; National Institute of Child Health and Human Development Neonatal Research Network. Heterogeneity of Treatment Effects of Hydrocortisone by Risk of Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants in the National Institute of Child Health and Human Development Neonatal Research Network Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315315. doi: 10.1001/jamanetworkopen.2023.15315.
PubMed 37256621Watterberg KL, Walsh MC, Li L, Chawla S, D'Angio CT, Goldberg RN, Hintz SR, Laughon MM, Yoder BA, Kennedy KA, McDavid GE, Backstrom-Lacy C, Das A, Crawford MM, Keszler M, Sokol GM, Poindexter BB, Ambalavanan N, Hibbs AM, Truog WE, Schmidt B, Wyckoff MH, Khan AM, Garg M, Chess PR, Reynolds AM, Moallem M, Bell EF, Meyer LR, Patel RM, Van Meurs KP, Cotten CM, McGowan EC, Hines AC, Merhar S, Peralta-Carcelen M, Wilson-Costello DE, Kilbride HW, DeMauro SB, Heyne RJ, Mosquera RA, Natarajan G, Purdy IB, Lowe JR, Maitre NL, Harmon HM, Hogden LA, Adams-Chapman I, Winter S, Malcolm WF, Higgins RD; Eunice Kennedy Shriver NICHD Neonatal Research Network. Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia. N Engl J Med. 2022 Mar 24;386(12):1121-1131. doi: 10.1056/NEJMoa2114897.
PubMed 35320643
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effect of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22 - 26 Months of Age in Intubated Infants < 30 Weeks Gestation Age
- ClinicalTrials.gov ID
- NCT01353313
- Acronym / sponsor ID
- NICHD-NRN-0045
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature, Bronchopulmonary Dysplasia
- Keywords
- NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Intubation, Neurodevelopmental impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 11 Aug 2011 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 13 May 2011 (estimated)
- Results
- Posted 19 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.
Detailed description
Bronchopulmonary dysplasia (BPD) remains a leading morbidity of the extremely preterm infant, and prolonged mechanical ventilation is associated with increased risk for BPD. Dexamethasone has been used previously to facilitate extubation and decrease the incidence of BPD; however, due to adverse effects on neurodevelopmental outcomes, the use of this drug has decreased. One cohort study suggests that hydrocortisone (HC) may facilitate extubation. HC has thus far not been associated with adverse neurodevelopmental outcomes in either cohort studies or randomized controlled trials. A recent meta-analysis of postnatal corticosteroid therapy begun after the first week of life suggested that "late therapy may reduce neonatal mortality without significantly increasing the risk of adverse long-term neurodevelopmental outcomes," although the methodological quality of some of the follow-up was acknowledged to be limited.
This is a randomized controlled trial to study the efficacy and safety of a 10-day tapering course of hydrocortisone treatment for infants <30 weeks estimated gestational age at birth who remain intubated at 14 - 28 days postnatal age. Based on previous Network data these criteria define a population with a risk of death or BPD at 36 weeks postmenstrual age of approximately 65 - 75%. The primary outcome for this study will incorporate both (1) survival without moderate to severe BPD by Network physiologic definition and (2) survival without moderate or severe NDI at 18 - 22 months corrected age. Therefore, the results of this study will be reported only when follow-up data are available unless (1) the trial is stopped early by the DSMC because of strong evidence of benefit or harm, or (2) at the time all subjects have completed treatment the DCC finds a substantial survival benefit favoring hydrocortisone (p<0.001). Individual study assignment will remain masked until the follow-up is completed. Secondary outcomes will include short term measures such as respiratory morbidities and growth at 36 weeks postmenstrual age and long term measures including growth and other outcomes at 22 - 26 months corrected age.
Secondary studies include:
- Effect of Hydrocortisone on the Cardiac mass of Premature Intubated Infants - will determine left ventricular mass index at 36 weeks postmenstrual age (or prior to discharge/transfer if after 34 weeks) in infants enrolled in the hydrocortisone for BPD RCT, and compare HC-treated infants to placebo-treated infants. It will similarly assess and compare the incidence of pulmonary hypertension in these patients.
- Extended follow-up: Subjects will be seen for a follow-up visit at 5-6 years corrected age to assess functional developmental and respiratory outcomes at early school age. In a subset of five Neonatal Research Network Clinical Centers, impulse oscillometry (IOS), which is the optimal direct measure of lung capacity and function, will be performed to validate the 6-minute walk test and International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire as functional measures of pulmonary status. Also at these five Centers, the six minute walk test, ISAAAC questionnaire, and IOS will be administered as part of (1) the Healthy Lungs sub-study, which will recruit 120 TOP 5 study participants who had minimal lung disease when they were infants to define normative ranges in healthy, preterm-born children, and (2) the Healthy Lungs Two sub-study, which will recruit 120 healthy, term-born children without history of lung disease to characterize functional and mechanical respiratory outcomes at 5-7 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSaline placebo |
| Hydrocortisone | Experimental | Drug: Hydrocortisonehydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents) |
Who may qualify
- Ages
- Up to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- infants <30 weeks estimated gestational age
- inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age
- have received at least 7days of mechanical ventilation;
- are receiving mechanical ventilation through an endotracheal tube .
Key exclusion criteria (6 listed)
- Major congenital anomalies
- Decision to limit support
- Indomethacin or ibuprofen treatment within 48 hours of study drug
- Previous corticosteroid treatment for BPD
- Received hydrocortisone for 14 or more cumulative days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneHydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows: 4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then 1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days | Drug | Hydrocortisone |
| PlaceboSaline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows: 4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then 1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days | Drug | Placebo |
Primary outcome
Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD)
Time frame: From day of randomization to 36 weeks post menstrual age
Survival without moderate or severe physiologic BPD at 36 weeks postmenstrual age. Moderate or severe physiologic BPD is defined as a requirement for supplemental oxygen and/or positive airway pressure to maintain oxygen saturation greater than 90 percent. A room air challenge was performed for infants estimated to be receiving less than 0.30 FiO2 by nasal cannula.
Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI)
Time frame: From day of randomization to 22-26 months corrected age
Survival without moderate or severe neurodevelopmental impairment (NDI) at 22-26 months corrected age. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction from less than 20 to 200), or bilateral hearing impairment with or without amplification (by report).
38 secondary outcomes
Number of Participants With Successful Extubation
Time frame: From day of randomization to day 14 post randomization
Total Deaths Before Discharge
Time frame: From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age
Time frame: At 36 weeks postmenstrual age
Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA)
Time frame: From birth to 36 weeks postmenstrual age
Duration of Oxygen Supplementation up to Status
Time frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Length of Hospital Stay in Days Among Survivors to Discharge
Time frame: From birth up to one year
Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA)
Time frame: From birth to 36 weeks postmenstrual age
Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI
Time frame: At 22-26 months corrected age
Number of Participants With Gross Motor Function Greater Than or Equal to Level 2
Time frame: At 22-26 months corrected age
Number of Participants With Moderate-severe Cerebral Palsy
Time frame: At 22-26 months corrected age
Number of Participants With Severe Hearing Impairment (by Report)
Time frame: At 22-26 months corrected age
Number of Participants With no/Some Functional Vision
Time frame: At 22-26 months corrected age
Weight Growth Measure Following Extremely Preterm Birth
Time frame: At 36 weeks post-menstrual age
Follow-up Weight Growth Measure Following Extremely Preterm Birth
Time frame: At 22-26 months corrected age
Length Growth Measure Following Extremely Preterm Birth
Time frame: At 36 weeks post-menstrual age
Follow-up Length Growth Measure Following Extremely Preterm Birth
Time frame: At 22-26 months corrected age
Head Circumference Growth Measure Following Extremely Preterm Birth
Time frame: At 36 weeks post-menstrual age
Follow-up Head Circumference Growth Measure Following Extremely Preterm Birth
Time frame: At 22-26 months corrected age
Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade 40 Weeks Postmenstrual Age
Time frame: At 40 weeks post menstrual age
Days of Mechanical Ventilation up to Status
Time frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Duration of Oxygen Supplementation Among Survivors to 36 Weeks
Time frame: From birth to 36 weeks postmenstrual age
Duration of Invasive Positive Pressure Ventilation (PPV) After Postnatal Day 14
Time frame: From postnatal day 15 to 36 weeks post menstrual age or Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Duration of Non-invasive Positive Pressure Ventilation (PPV) (Nasal IPPV/CPAP) After Postnatal Day 14
Time frame: From postnatal day 15 to 36 weeks post menstrual age or Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants Who Received Inhaled Glucocorticoids During Study Period
Time frame: From randomization to day 14 post randomization
Number of Participants Who Received Other Systemic Glucocorticoids During Study Period
Time frame: From randomization to day 14 post randomization
Number of Days Dexamethasone Given Before 36 Weeks PMA
Time frame: From birth to 36 weeks postmenstrual age
Number of Participants With Patent Ductus Arteriosus (PDA) Treated With Medication or Surgery
Time frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants Diagnosed With Necrotizing Enterocolitis (NEC)
Time frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Retinopathy of Prematurity (ROP) Stage 3 or Worse
Time frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants Receiving Therapy for Retinopathy of Prematurity (ROP)
Time frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Severe Intraventricular Hemorrhage (IVH)
Time frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Periventricular Leukomalacia
Time frame: From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Number of Participants With Neurodevelopmental Impairment (NDI)
Time frame: At 22-26 months corrected age
Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 85
Time frame: At 22-26 months corrected age
Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 70
Time frame: At 22-26 months corrected age
Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 85
Time frame: At 22-26 months corrected age
Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 70
Time frame: At 22-26 months corrected age
Number of Participants With Any Cerebral Palsy
Time frame: At 22-26 months corrected age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41359352DeMauro SB, Kirpalani H, Hintz S, Watterberg KL, Watson V, Lowe J, Shankaran S, Chawla S, Vohr B, Msall ME, D'Angio CT, Yoder BA, Lai K, Winter S, Colaizy TT, Merhar SL, Ziolkowski K, Bann CM, Trotta M, Newman JE, Walsh MC, Higgins RD, Cahill TE, Duncan AF, Wilson-Costello DE, Peralta-Carcelen M, Arnold H, Mosquera RA, Heyne RJ, Fuller J, McGowan EC, Cavanaugh B, Harmon HM, Maitre NL, Neel ML, Van Meurs KP, Richards LA, Kilbride HW, Hines AC, Natarajan G, Trembath A, Benninger KL, Kesavan K, Malcolm WF, Zanger D, Reynolds AM, Carlson M, Das A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Hydrocortisone in Preterm Infants and School-Age Functional Outcomes: Follow-Up of a Randomized Clinical Trial. JAMA Pediatr. 2026 Feb 1;180(2):134-143. doi: 10.1001/jamapediatrics.2025.4801.
- Derived from this study: PubMed 40090543Sankar MN, Chock V, Myers F, Davis AS, McDonald S, Rysavy MA, Laughon M, Bhombal S, Van Meurs KP, Das A, Benitz WE, Watterberg K; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Patent Ductus Arteriosus, Hydrocortisone, and Outcome among Infants Born Extremely Preterm: Secondary Analysis of the Hydrocortisone Trial. J Pediatr. 2025 Jun;281:114535. doi: 10.1016/j.jpeds.2025.114535. Epub 2025 Mar 14.
- Derived from this study: PubMed 39543521DeMauro SB, Kirpalani H, Ziolkowski K, Hintz S, Watterberg K, Lowe J, Shankaran S, Chawla S, Vohr B, Msall M, D'Angio C, Yoder BA, Lai K, Winter S, Colaizy T, Merhar S, Bann CM, Trotta M, Newman J, Natarajan A, Das A. The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for a longitudinal cohort study. BMC Pediatr. 2024 Nov 14;24(1):737. doi: 10.1186/s12887-024-05198-9.
- Derived from this study: PubMed 37256621Gentle SJ, Rysavy MA, Li L, Laughon MM, Patel RM, Jensen EA, Hintz S, Ambalavanan N, Carlo WA, Watterberg K; National Institute of Child Health and Human Development Neonatal Research Network. Heterogeneity of Treatment Effects of Hydrocortisone by Risk of Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants in the National Institute of Child Health and Human Development Neonatal Research Network Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315315. doi: 10.1001/jamanetworkopen.2023.15315.
- Derived from this study: PubMed 35320643Watterberg KL, Walsh MC, Li L, Chawla S, D'Angio CT, Goldberg RN, Hintz SR, Laughon MM, Yoder BA, Kennedy KA, McDavid GE, Backstrom-Lacy C, Das A, Crawford MM, Keszler M, Sokol GM, Poindexter BB, Ambalavanan N, Hibbs AM, Truog WE, Schmidt B, Wyckoff MH, Khan AM, Garg M, Chess PR, Reynolds AM, Moallem M, Bell EF, Meyer LR, Patel RM, Van Meurs KP, Cotten CM, McGowan EC, Hines AC, Merhar S, Peralta-Carcelen M, Wilson-Costello DE, Kilbride HW, DeMauro SB, Heyne RJ, Mosquera RA, Natarajan G, Purdy IB, Lowe JR, Maitre NL, Harmon HM, Hogden LA, Adams-Chapman I, Winter S, Malcolm WF, Higgins RD; Eunice Kennedy Shriver NICHD Neonatal Research Network. Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia. N Engl J Med. 2022 Mar 24;386(12):1121-1131. doi: 10.1056/NEJMoa2114897.
- NICHD Neonatal Research Network siteLink provided by the sponsor.
- NICHD Pregnancy \& Perinatology BranchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele C Walsh, MD principal investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
Seetha Shankaran, MD principal investigator
Wayne State University
Abbot R Laptook, MD principal investigator
Brown University, Women & Infants Hospital of Rhode Island
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone in people with Infant, Newborn and Infant, Small for Gestational Age, run by NICHD Neonatal Research Network at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) (time frame: From day of randomization to 36 weeks post menstrual age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01353313, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.