Pulmonary HypertensionPhase 1/2NCT03576885
Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia
A Phase 1/2 study testing inhaled nitric oxide in people with Pulmonary Hypertension and Bronchopulmonary Dysplasia, run by AdventHealth at 1 site in United States.
Trial summary
Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or death. In multiple clinical trials, iNO treatment was not effective for BPD prevention. Read more about this study
- Who is it for?
- Ages 23 to 29 weeks
- Conditions the study is for
- Pulmonary Hypertension, Bronchopulmonary Dysplasia
- What is being tested?
- inhaled nitric oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 9 Oct 2023
- Phase
- Phase 1/2
- 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 23 to 29 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Step 1:
- Birth between 23 weeks and 0 days and 29 weeks and 6 days.
- Positive pressure ventilation at 72-96 hours of age
- Step 2:
- Early pulmonary hypertension
Who cannot join
- Step 1:
- Death prior to 12 hours of age or first echocardiogram
- Chromosomal anomalies
- Major congenital anomalies
- Myocardial dysfunction
- Complex cardiac defect
Show all 13Show fewer
- Dependent on right to left shunting of blood
- Step 2:
- Excessive pulmonary blood flow (left to right shunt across PDA)
- Pulmonary blood flow obstruction secondary to pulmonary vein stenosis
- Mitral valve stenosis
- Cor triata
- Aortic valve atresia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Delayed Pulmonary Transition in Extremely Preterm Infants & Bronchopulmonary Dysplasia
Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or death. In multiple clinical trials, iNO treatment was not effective for BPD prevention. However, infants were not screened for PH and iNO treatment was not targeted for PH. iNO treatment for PH in preterm infants is controversial due to lack of evidence. The study team hypothesizes that early diagnosis of PH (72-96 hours of life) and iNO treatment will decrease the incidence of death and bronchopulmonary dysplasia and improve oxygenation in extremely preterm infants.
- To determine if iNO treatment of extremely preterm infants with early pulmonary hypertension as established with echocardiographic evidence at 72-96 hours of age will decrease incidence of death or BPD.
- To determine if iNO treatment of extremely preterm infants with early PH will decrease the pulmonary artery pressure and improve oxygenation within 72 hours of intervention.
Read the detailed description
This is a single center, blinded, randomized control clinical trial to evaluate the effects of inhaled nitric oxide on the outcome of survival and incidence of bronchopulmonary dysplasia. This trial has a planned enrollment of 138 infants with 68 infants with delayed pulmonary transition assigned to either the treatment or placebo group. There is no enrollment restriction based on gender, ethnicity, or race. Enrollment is expected to take 36 months with an additional 12 months for data analysis.Infants with early pulmonary hypertension will be randomized to the treatment or placebo group. Treatment will continue until resolution of pulmonary hypertension or through Day 14, whichever comes first. Serial echocardiograms will be performed every 48 hours +/-12 hours until Day 14. Oxygen saturation levels will be averaged every 24 hour period following enrollment. This study will provide evidence for the beneficial effects of early diagnosis and treatment of pulmonary hypertension in preterm infants.
- Conditions
- Pulmonary Hypertension, Bronchopulmonary Dysplasia
- Being tested
- inhaled nitric oxide, Placebo
- Medical subject headings
- Hypertension, Pulmonary, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled nitric oxideDrug
Also called iNO
inhaled nitric oxide will be administered starting at 20 ppm. Treatment will continue for 14 days or until resolution of pulmonary hypertension
PlaceboDrug
placebo will be administered starting at 20 ppm. Treatment will continue for 14 days or until resolution of pulmonary hypertension
| Study group | Role | What they receive |
|---|---|---|
| Treatment group - active | Active comparator | inhaled nitric oxide treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first. Receives: Drug: inhaled nitric oxide |
| Treatment group - placebo | Placebo comparator | Placebo treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first. Receives: Drug: Placebo |
| Control group | No intervention | Enrolled infants with no evidence of pulmonary hypertension will serve as the control group for incidence of death or bronchopulmonary hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Incidence of death
Measured: 36 weeks post menstrual age
Bronchopulmonary (BPD) Dysplasia (Yes/no)
Incidence of bronchopulmonary dysplasia as determined by need for positive pressure ventilation or supplemental oxygen after room air challenge test
Measured: 36 weeks post menstrual age
Secondary outcomes (1)
Pulmonary Hypertension
Pulmonary arterial pressure will be evaluated every 24-48 hours after enrollment.
Measured: Duration of treatment or up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start15 Jul 2019
- Primary completion9 Oct 2023
- Study completion9 Oct 2023
Why it stopped: based on DSMB recommendation at interim analysis
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 (31)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Masked randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt, Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Hussnain Mirza, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576885
- Sponsor's protocol ID
- 1170748
- Status last verified
- Jan 2025
- First submitted
- 22 Jun 2018
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Laughon MM, Langer JC, Bose CL, Smith PB, Ambalavanan N, Kennedy KA, Stoll BJ, Buchter S, Laptook AR, Ehrenkranz RA, Cotten CM, Wilson-Costello DE, Shankaran S, Van Meurs KP, Davis AS, Gantz MG, Finer NN, Yoder BA, Faix RG, Carlo WA, Schibler KR, Newman NS, Rich W, Das A, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Prediction of bronchopulmonary dysplasia by postnatal age in extremely premature infants. Am J Respir Crit Care Med. 2011 Jun 15;183(12):1715-22. doi: 10.1164/rccm.201101-0055OC. Epub 2011 Mar 4.
PubMed 21471086Ballard RA, Keller RL, Black DM, Ballard PL, Merrill JD, Eichenwald EC, Truog WE, Mammel MC, Steinhorn RH, Rogers EE, Ryan RM, Durand DJ, Asselin JM, Bendel CM, Bendel-Stenzel EM, Courtney SE, Dhanireddy R, Hudak ML, Koch FR, Mayock DE, McKay VJ, O'Shea TM, Porta NF, Wadhawan R, Palermo L; TOLSURF Study Group. Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide. J Pediatr. 2016 Jan;168:23-29.e4. doi: 10.1016/j.jpeds.2015.09.031. Epub 2015 Oct 21.
PubMed 26500107Khemani E, McElhinney DB, Rhein L, Andrade O, Lacro RV, Thomas KC, Mullen MP. Pulmonary artery hypertension in formerly premature infants with bronchopulmonary dysplasia: clinical features and outcomes in the surfactant era. Pediatrics. 2007 Dec;120(6):1260-9. doi: 10.1542/peds.2007-0971.
PubMed 18055675West JB, Mathieu-Costello O. Stress failure of pulmonary capillaries as a limiting factor for maximal exercise. Eur J Appl Physiol Occup Physiol. 1995;70(2):99-108. doi: 10.1007/BF00361536.
PubMed 7768245Mirza H, Ziegler J, Ford S, Padbury J, Tucker R, Laptook A. Pulmonary hypertension in preterm infants: prevalence and association with bronchopulmonary dysplasia. J Pediatr. 2014 Nov;165(5):909-14.e1. doi: 10.1016/j.jpeds.2014.07.040. Epub 2014 Sep 1.
PubMed 25189821Bhat R, Salas AA, Foster C, Carlo WA, Ambalavanan N. Prospective analysis of pulmonary hypertension in extremely low birth weight infants. Pediatrics. 2012 Mar;129(3):e682-9. doi: 10.1542/peds.2011-1827. Epub 2012 Feb 6.
PubMed 22311993Mourani PM, Sontag MK, Younoszai A, Miller JI, Kinsella JP, Baker CD, Poindexter BB, Ingram DA, Abman SH. Early pulmonary vascular disease in preterm infants at risk for bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2015 Jan 1;191(1):87-95. doi: 10.1164/rccm.201409-1594OC.
PubMed 25389562Ambalavanan N, Mourani P. Pulmonary hypertension in bronchopulmonary dysplasia. Birth Defects Res A Clin Mol Teratol. 2014 Mar;100(3):240-6. doi: 10.1002/bdra.23241. Epub 2014 Mar 10.
PubMed 24616323Finer NN, Evans N. Inhaled nitric oxide for the preterm infant: evidence versus practice. Pediatrics. 2015 Apr;135(4):754-6. doi: 10.1542/peds.2015-0144. Epub 2015 Mar 9. No abstract available.
PubMed 25755239Kinsella JP, Steinhorn RH, Krishnan US, Feinstein JA, Adatia I, Austin ED, Rosenzweig EB, Everett AD, Fineman JR, Hanna BD, Hopper RK, Humpl T, Ivy DD, Keller RL, Mullen MP, Raj JU, Wessel DL, Abman SH. Recommendations for the Use of Inhaled Nitric Oxide Therapy in Premature Newborns with Severe Pulmonary Hypertension. J Pediatr. 2016 Mar;170:312-4. doi: 10.1016/j.jpeds.2015.11.050. Epub 2015 Dec 15. No abstract available.
PubMed 26703869Abman SH, Kinsella JP, Schaffer MS, Wilkening RB. Inhaled nitric oxide in the management of a premature newborn with severe respiratory distress and pulmonary hypertension. Pediatrics. 1993 Oct;92(4):606-9. No abstract available.
PubMed 8414836Ambalavanan N, Aschner JL. Management of hypoxemic respiratory failure and pulmonary hypertension in preterm infants. J Perinatol. 2016 Jun;36 Suppl 2:S20-7. doi: 10.1038/jp.2016.45.
PubMed 27225961Askie LM, Ballard RA, Cutter GR, Dani C, Elbourne D, Field D, Hascoet JM, Hibbs AM, Kinsella JP, Mercier JC, Rich W, Schreiber MD, Wongsiridej PS, Subhedar NV, Van Meurs KP, Voysey M, Barrington K, Ehrenkranz RA, Finer NN; Meta-analysis of Preterm Patients on Inhaled Nitric Oxide Collaboration. Inhaled nitric oxide in preterm infants: an individual-patient data meta-analysis of randomized trials. Pediatrics. 2011 Oct;128(4):729-39. doi: 10.1542/peds.2010-2725. Epub 2011 Sep 19.
PubMed 21930540Truog WE, Ballard PL, Norberg M, Golombek S, Savani RC, Merrill JD, Parton LA, Cnaan A, Luan X, Ballard RA; Nitric Oxide (to Prevent) Chronic Lung Disease Study Investigators. Inflammatory markers and mediators in tracheal fluid of premature infants treated with inhaled nitric oxide. Pediatrics. 2007 Apr;119(4):670-8. doi: 10.1542/peds.2006-2683.
PubMed 17403837Posencheg MA, Gow AJ, Truog WE, Ballard RA, Cnaan A, Golombek SG, Ballard PL; NO CLD Investigators. Inhaled nitric oxide in premature infants: effect on tracheal aspirate and plasma nitric oxide metabolites. J Perinatol. 2010 Apr;30(4):275-80. doi: 10.1038/jp.2009.155. Epub 2009 Oct 8.
PubMed 19812581
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Delayed Pulmonary Transition in Extremely Preterm Infants & Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT03576885
- Acronym / sponsor ID
- 1170748
- Conditions
- Pulmonary Hypertension, Bronchopulmonary Dysplasia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: based on DSMB recommendation at interim analysis
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Mallinckrodt, Thrasher Research Fund
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or death. In multiple clinical trials, iNO treatment was not effective for BPD prevention. However, infants were not screened for PH and iNO treatment was not targeted for PH. iNO treatment for PH in preterm infants is controversial due to lack of evidence. The study team hypothesizes that early diagnosis of PH (72-96 hours of life) and iNO treatment will decrease the incidence of death and bronchopulmonary dysplasia and improve oxygenation in extremely preterm infants.
- To determine if iNO treatment of extremely preterm infants with early pulmonary hypertension as established with echocardiographic evidence at 72-96 hours of age will decrease incidence of death or BPD.
- To determine if iNO treatment of extremely preterm infants with early PH will decrease the pulmonary artery pressure and improve oxygenation within 72 hours of intervention.
Detailed description
This is a single center, blinded, randomized control clinical trial to evaluate the effects of inhaled nitric oxide on the outcome of survival and incidence of bronchopulmonary dysplasia. This trial has a planned enrollment of 138 infants with 68 infants with delayed pulmonary transition assigned to either the treatment or placebo group. There is no enrollment restriction based on gender, ethnicity, or race. Enrollment is expected to take 36 months with an additional 12 months for data analysis.Infants with early pulmonary hypertension will be randomized to the treatment or placebo group. Treatment will continue until resolution of pulmonary hypertension or through Day 14, whichever comes first. Serial echocardiograms will be performed every 48 hours +/-12 hours until Day 14. Oxygen saturation levels will be averaged every 24 hour period following enrollment. This study will provide evidence for the beneficial effects of early diagnosis and treatment of pulmonary hypertension in preterm infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Masked randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group - active | Active comparator | Drug: inhaled nitric oxideinhaled nitric oxide treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first. |
| Treatment group - placebo | Placebo comparator | Drug: PlaceboPlacebo treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first. |
| Control group | No intervention | –Enrolled infants with no evidence of pulmonary hypertension will serve as the control group for incidence of death or bronchopulmonary hypertension |
Who may qualify
- Ages
- 23 to 29 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Birth between 23 weeks and 0 days and 29 weeks and 6 days.
- Positive pressure ventilation at 72-96 hours of age
- Early pulmonary hypertension
Key exclusion criteria (13 listed)
- Death prior to 12 hours of age or first echocardiogram
- Chromosomal anomalies
- Major congenital anomalies
- Myocardial dysfunction
- Complex cardiac defect
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 |
|---|---|---|
| inhaled nitric oxideAlso: iNOinhaled nitric oxide will be administered starting at 20 ppm. Treatment will continue for 14 days or until resolution of pulmonary hypertension | Drug | Treatment group - active |
| Placeboplacebo will be administered starting at 20 ppm. Treatment will continue for 14 days or until resolution of pulmonary hypertension | Drug | Treatment group - placebo |
Primary outcome
Death
Time frame: 36 weeks post menstrual age
Incidence of death
Bronchopulmonary (BPD) Dysplasia (Yes/no)
Time frame: 36 weeks post menstrual age
Incidence of bronchopulmonary dysplasia as determined by need for positive pressure ventilation or supplemental oxygen after room air challenge test
1 secondary outcome
Pulmonary Hypertension
Time frame: Duration of treatment or up to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21471086Laughon MM, Langer JC, Bose CL, Smith PB, Ambalavanan N, Kennedy KA, Stoll BJ, Buchter S, Laptook AR, Ehrenkranz RA, Cotten CM, Wilson-Costello DE, Shankaran S, Van Meurs KP, Davis AS, Gantz MG, Finer NN, Yoder BA, Faix RG, Carlo WA, Schibler KR, Newman NS, Rich W, Das A, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Prediction of bronchopulmonary dysplasia by postnatal age in extremely premature infants. Am J Respir Crit Care Med. 2011 Jun 15;183(12):1715-22. doi: 10.1164/rccm.201101-0055OC. Epub 2011 Mar 4.
- Background: PubMed 26500107Ballard RA, Keller RL, Black DM, Ballard PL, Merrill JD, Eichenwald EC, Truog WE, Mammel MC, Steinhorn RH, Rogers EE, Ryan RM, Durand DJ, Asselin JM, Bendel CM, Bendel-Stenzel EM, Courtney SE, Dhanireddy R, Hudak ML, Koch FR, Mayock DE, McKay VJ, O'Shea TM, Porta NF, Wadhawan R, Palermo L; TOLSURF Study Group. Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide. J Pediatr. 2016 Jan;168:23-29.e4. doi: 10.1016/j.jpeds.2015.09.031. Epub 2015 Oct 21.
- Background: PubMed 18055675Khemani E, McElhinney DB, Rhein L, Andrade O, Lacro RV, Thomas KC, Mullen MP. Pulmonary artery hypertension in formerly premature infants with bronchopulmonary dysplasia: clinical features and outcomes in the surfactant era. Pediatrics. 2007 Dec;120(6):1260-9. doi: 10.1542/peds.2007-0971.
- Background: PubMed 7768245West JB, Mathieu-Costello O. Stress failure of pulmonary capillaries as a limiting factor for maximal exercise. Eur J Appl Physiol Occup Physiol. 1995;70(2):99-108. doi: 10.1007/BF00361536.
- Background: PubMed 25189821Mirza H, Ziegler J, Ford S, Padbury J, Tucker R, Laptook A. Pulmonary hypertension in preterm infants: prevalence and association with bronchopulmonary dysplasia. J Pediatr. 2014 Nov;165(5):909-14.e1. doi: 10.1016/j.jpeds.2014.07.040. Epub 2014 Sep 1.
- Background: PubMed 22311993Bhat R, Salas AA, Foster C, Carlo WA, Ambalavanan N. Prospective analysis of pulmonary hypertension in extremely low birth weight infants. Pediatrics. 2012 Mar;129(3):e682-9. doi: 10.1542/peds.2011-1827. Epub 2012 Feb 6.
- Background: PubMed 25389562Mourani PM, Sontag MK, Younoszai A, Miller JI, Kinsella JP, Baker CD, Poindexter BB, Ingram DA, Abman SH. Early pulmonary vascular disease in preterm infants at risk for bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2015 Jan 1;191(1):87-95. doi: 10.1164/rccm.201409-1594OC.
- Background: PubMed 24616323Ambalavanan N, Mourani P. Pulmonary hypertension in bronchopulmonary dysplasia. Birth Defects Res A Clin Mol Teratol. 2014 Mar;100(3):240-6. doi: 10.1002/bdra.23241. Epub 2014 Mar 10.
- Background: PubMed 25755239Finer NN, Evans N. Inhaled nitric oxide for the preterm infant: evidence versus practice. Pediatrics. 2015 Apr;135(4):754-6. doi: 10.1542/peds.2015-0144. Epub 2015 Mar 9. No abstract available.
- Background: PubMed 26703869Kinsella JP, Steinhorn RH, Krishnan US, Feinstein JA, Adatia I, Austin ED, Rosenzweig EB, Everett AD, Fineman JR, Hanna BD, Hopper RK, Humpl T, Ivy DD, Keller RL, Mullen MP, Raj JU, Wessel DL, Abman SH. Recommendations for the Use of Inhaled Nitric Oxide Therapy in Premature Newborns with Severe Pulmonary Hypertension. J Pediatr. 2016 Mar;170:312-4. doi: 10.1016/j.jpeds.2015.11.050. Epub 2015 Dec 15. No abstract available.
- Background: PubMed 8414836Abman SH, Kinsella JP, Schaffer MS, Wilkening RB. Inhaled nitric oxide in the management of a premature newborn with severe respiratory distress and pulmonary hypertension. Pediatrics. 1993 Oct;92(4):606-9. No abstract available.
- Background: PubMed 27225961Ambalavanan N, Aschner JL. Management of hypoxemic respiratory failure and pulmonary hypertension in preterm infants. J Perinatol. 2016 Jun;36 Suppl 2:S20-7. doi: 10.1038/jp.2016.45.
- Individual participant dataSharing planned: Undecided
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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.
Hussnain Mirza, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing inhaled nitric oxide in people with Pulmonary Hypertension and Bronchopulmonary Dysplasia, run by AdventHealth at 1 site 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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Jan 2025). 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?
Death (time frame: 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 NCT03576885, which also lists 31 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 15 Jan 2025.