BPD - Bronchopulmonary DysplasiaNCT04246333
Duodenal Feeds in Very Low Birth Weight Infants
A study testing Mode of Delivery of Feeds in people with BPD - Bronchopulmonary Dysplasia and VLBW - Very Low Birth Weight Infant, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial summary
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Read more about this study
- Who is it for?
- Ages 0 days to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal
- What is being tested?
- Mode of Delivery of Feeds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2020to 19 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 days to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants admitted to the Johns Hopkins All Children's NICU before 72 hours of life
- Infants with a birth weight <1251g
Who cannot join
- First obtained pH <7.0
- APGAR <5 at 5 minutes (The Apgar score is a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. Appearance, Pulse, Grimace, Activity, Respiration (APGAR))
- Infants on hydrocortisone for hypotension prior to randomization
- Infants with intrauterine growth restriction (IUGR) defined by birth weight ≤10th percentile for gestational age
- Infants with congenital anomalies, including but not limited to: Chromosomal abnormalities;Structural airway or pulmonary abnormalities (e.g. tracheoesophageal fistulas, cleft palate, congenital pulmonary adenomatous malformation, etc.); Abdominal anomalies requiring surgical interventions (e.g. intestinal atresia, intestinal webs, gastroschisis, omphalocele, anal atresia); Major cardiac anomalies
- Infants with a history of intestinal perforation or NEC
- Presence of gastrostomy tube
- Infants who have not been initiated on any volume of enteral feeds by 10 days of life
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Feasibility and Safety of Duodenal Feeds in Very Low Birth Weight Infants
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Transpyloric feeds, specifically duodenal feeds, may be used to bypass the stomach and directly feed the duodenum decreasing the amount of gastric reflux contributing to aspiration. Duodenal feeds are equivalent to gastric feeds with regards to nutritional outcomes, and have been shown to decrease events of apnea and bradycardia in premature infants. This study will evaluate the feasibility and safety of duodenal feeds in premature infants. The hypothesis is that duodenal feeds may be safely and successfully performed in premature very low birth weight infants.
Read the detailed description
The primary outcome of this study is the safety and feasibility of duodenal feeds in very low birth weight infants. The secondary outcomes are various measures related to growth, respiratory support, comorbidities, and hospitalization.
Eligibility of infants admitted to the Johns Hopkins All Children's Neonatal Intensive Care Unit (NICU) will be determined based on inclusion and exclusion criteria. Eligible infants will be recruited and enrolled by 14 days of life after informed consent is obtained. Randomization of the infants into two groups- investigational continuous Duodenal Feeds (DF) or standard Gastric Feeds (GF) - will occur just prior to the infants advancing beyond 50mL/kg/day of enteral feeds.
All enrolled infants will be fed per the institutional feeding protocol. Once infants advance past 50mL/kg/day of enteral feeds, at this point infants will be randomized to DF or GF groups in a 1:1 block randomization using blinded envelopes. Multiple gestation infants will be randomized individually.
Placement of gastric tubes will be per standard of practice, and insertion of duodenal tube will be per manual of operations. Continuous duodenal feeds will be provided over 24 hours as a continuous infusion through a nasoduodenal or oro-duodenal tube. Standard gastric feeds will be infused via a nasogastric or orogastric tube per the instructions of the medical team. Gastric feeds are provided as standard of care in the NICU; intermittent bolus feeds over 15-60 minutes. Feeding time may be prolonged by the medical team, for longer than 60 minutes and possibly even be given continuously, for various reasons (emesis, reflux, apnea, bradycardia, etc.) and will be monitored and recorded. Feed volume and advancement will continue to be determined by standardized institutional feeding guidelines. Decision to provide further fortification of feeds beyond institutional guidelines will be determined by the medical team and not standardized in this protocol. Once full enteral feeds are achieved (total fluid goal of at least 140mL/kg/day), patients will continue to receive feeds via the designated route.
An institutional "Infant Driven Feeding Guideline" is utilized to evaluate readiness to orally feed and to transition premature infants from enteral to oral feeds. Once an infant is eligible to receive oral feeds per this guideline (32 weeks postmenstrual age, and tolerating ≤2L flow via nasal cannula for at least 24 hours), the study will allow the medical team to transition infants in the DF group to gastric feeds. Regarding transitioning infant from duodenal to gastric feeds, infants are initially placed on continuous gastric feeds, and once the participants have demonstrated tolerance (no evidence of reflux, increased respiratory support, emesis), the participants are then transitioned to bolus gastric feeds progressively. Infants may be allowed to orally feed during this transition period if the participants meet the appropriate infant driven feeding scores per protocol.
All infants in this study will be monitored for primary and secondary outcomes through the duration of admission and up until the time of discharge. Safety events will be frequently monitored for throughout the duration of admission and addressed immediately if warranted.
- Conditions
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn, Premature Birth, Chronic Lung Disease of Prematurity
- Being tested
- Mode of Delivery of Feeds
- Keywords
- Duodenal feeds, Transpyloric feeds, Bronchopulmonary Dysplasia, BPD, Premature infant, Neonate
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mode of Delivery of FeedsOther
Eligible infants will be recruited and enrolled and randomized to either duodenal feeds (DF) or gastric feeds (GF), which will occur just prior to the infants advancing beyond 50mL/kg/day of enteral feeds. All enrolled infants will be fed per our institutional feeding protocol. Once infants advance past a volume of 50mL/kg/day of enteral feeds, at this point infants will be randomized to DF or GF groups.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Feeds | No intervention | Patients in this arm will receive feeds via the standard route which is gastric feeds. |
| Duodenal Feeds | Experimental | Patients in this arm will receive feeds via the experimental route which is duodenal feeds. Receives: Other: Mode of Delivery of Feeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful placements of duodenal tubes
Success to be measured by appropriate placement of the duodenal tube within the duodenum as confirmed by radiographic imaging.
Measured: 12 months
Safety as assessed by number of intestinal perforations
Safety of duodenal feeds in very low birth weight infants as measured by the number of intestinal perforations secondary to placement of duodenal tube.
Measured: 12 months
Secondary outcomes (20)
Supplemental oxygen requirement
Number of days on supplemental oxygen >21% throughout duration of hospitalization
Measured: duration of hospitalization, up to 15 months
Number of participants with Bronchopulmonary Dysplasia
Mild, moderate, severe Bronchopulmonary Dysplasia (BPD) as defined by the NICHD/NHLBI/ORD Workshop published in 2001
Measured: 15 months
Number of deaths during hospitalization
Measured: 15 months
Number of days of mechanical ventilation
Days of invasive mechanical ventilation up until hospital discharge
Measured: 15 months
Number of participants with late-onset sepsis
Number of participants diagnosed with Culture-positive sepsis after 72 hours of life
Measured: 15 months
Central line days
Cumulative days of indwelling central venous catheters (peripherally inserted central catheters, tunneled venous catheters, umbilical venous catheters)
Measured: 15 months
Number of participants with necrotizing enterocolitis
Number of participants with necrotizing enterocolitis (NEC) defined by Modified Bells Stage II or greater
Measured: 15 months
Number of replaced enteral tubes
Number of replaced enteral tubes, gastric or duodenal, per patient
Measured: 15 months
Number of Radiographs related to enteral tube placement
Number of radiographs obtained with the indication of enteral tube placement, gastric or duodenal
Measured: 15 months
Weight percentile at 36 weeks postmenstrual age
Weight percentile at 36 weeks postmenstrual age
Measured: At 36 weeks
Height percentile at 36 weeks postmenstrual age
Height percentile at 36 weeks postmenstrual age
Measured: At 36 weeks
Head circumference percentile at 36 weeks postmenstrual age
Head circumference percentile at 36 weeks postmenstrual age
Measured: At 36 weeks
Z-scores for weight at 36 weeks postmenstrual age
Z-scores for weight at 36 weeks postmenstrual age calculated using PediTools
Measured: At 36 weeks
Z-scores for height at 36 weeks postmenstrual age
Z-scores for height at 36 weeks postmenstrual age calculated using PediTools
Measured: At 36 weeks
Z-scores for head circumference at 36 weeks postmenstrual age
Z-scores for head circumference at 36 weeks postmenstrual age calculated using PediTools
Measured: At 36 weeks
Daily daily weight gain
Average daily weight gain (kg/day) calculated from birth until 36 weeks postmenstrual age using the fetal-infant growth reference (FIGR) equation
Measured: At 36 weeks
Length of stay
Length of hospital stay (days)
Measured: duration of hospitalization, up to 15 months
Need for excess fortification of feeds
Number of participants requiring fortification beyond 24kcal/oz
Measured: 15 months
Use of postnatal dexamethasone
Number of participants requiring use of postnatal dexamethasone for respiratory indications
Measured: 15 months
Use of chronic diuretics
Number of participants requiring use of chronic diuretics including thiazide diuretics and spironolactone
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start7 Aug 2020
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for BPD - Bronchopulmonary DysplasiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noura Nickel, MD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246333
- Sponsor's protocol ID
- IRB00217658
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2020
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
PubMed 11401896Fenton TR, Nasser R, Eliasziw M, Kim JH, Bilan D, Sauve R. Validating the weight gain of preterm infants between the reference growth curve of the fetus and the term infant. BMC Pediatr. 2013 Jun 11;13:92. doi: 10.1186/1471-2431-13-92.
PubMed 23758808Shennan AT, Dunn MS, Ohlsson A, Lennox K, Hoskins EM. Abnormal pulmonary outcomes in premature infants: prediction from oxygen requirement in the neonatal period. Pediatrics. 1988 Oct;82(4):527-32.
PubMed 3174313Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
PubMed 20732945Poets CF. Gastroesophageal reflux: a critical review of its role in preterm infants. Pediatrics. 2004 Feb;113(2):e128-32. doi: 10.1542/peds.113.2.e128.
PubMed 14754982Omari TI, Barnett CP, Benninga MA, Lontis R, Goodchild L, Haslam RR, Dent J, Davidson GP. Mechanisms of gastro-oesophageal reflux in preterm and term infants with reflux disease. Gut. 2002 Oct;51(4):475-9. doi: 10.1136/gut.51.4.475.
PubMed 12235066Garland JS, Alex CP, Johnston N, Yan JC, Werlin SL. Association between tracheal pepsin, a reliable marker of gastric aspiration, and head of bed elevation among ventilated neonates. J Neonatal Perinatal Med. 2014 Jan 1;7(3):185-92. doi: 10.3233/NPM-14814020.
PubMed 25318633Peter CS, Wiechers C, Bohnhorst B, Silny J, Poets CF. Influence of nasogastric tubes on gastroesophageal reflux in preterm infants: a multiple intraluminal impedance study. J Pediatr. 2002 Aug;141(2):277-9. doi: 10.1067/mpd.2002.126298.
PubMed 12183728Jolley SG, Halpern CT, Sterling CE, Feldman BH. The relationship of respiratory complications from gastroesophageal reflux to prematurity in infants. J Pediatr Surg. 1990 Jul;25(7):755-7. doi: 10.1016/s0022-3468(05)80012-0.
PubMed 2380892Farhath S, Aghai ZH, Nakhla T, Saslow J, He Z, Soundar S, Mehta DI. Pepsin, a reliable marker of gastric aspiration, is frequently detected in tracheal aspirates from premature ventilated neonates: relationship with feeding and methylxanthine therapy. J Pediatr Gastroenterol Nutr. 2006 Sep;43(3):336-41. doi: 10.1097/01.mpg.0000232015.56155.03.
PubMed 16954956Knight PR, Davidson BA, Nader ND, Helinski JD, Marschke CJ, Russo TA, Hutson AD, Notter RH, Holm BA. Progressive, severe lung injury secondary to the interaction of insults in gastric aspiration. Exp Lung Res. 2004 Oct-Nov;30(7):535-57. doi: 10.1080/01902140490489162.
PubMed 15371091Blondheim O, Abbasi S, Fox WW, Bhutani VK. Effect of enteral gavage feeding rate on pulmonary functions of very low birth weight infants. J Pediatr. 1993 May;122(5 Pt 1):751-5. doi: 10.1016/s0022-3476(06)80021-1.
PubMed 8496756Jensen EA, Munson DA, Zhang H, Blinman TA, Kirpalani H. Anti-gastroesophageal reflux surgery in infants with severe bronchopulmonary dysplasia. Pediatr Pulmonol. 2015 Jun;50(6):584-7. doi: 10.1002/ppul.23052. Epub 2014 Apr 21.
PubMed 24753497McGuire W, McEwan P. Transpyloric versus gastric tube feeding for preterm infants. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003487. doi: 10.1002/14651858.CD003487.pub2.
PubMed 17636725Wells DH, Zachman RD. Nasojejunal feedings in low-birth-weight infants. J Pediatr. 1975 Aug;87(2):276-9. doi: 10.1016/s0022-3476(75)80602-0.
PubMed 807697
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Duodenal Feeds in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT04246333
- Acronym / sponsor ID
- IRB00217658
- Conditions
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn, Premature Birth, Chronic Lung Disease of Prematurity
- Keywords
- Duodenal feeds, Transpyloric feeds, Bronchopulmonary Dysplasia, BPD, Premature infant, Neonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Transpyloric feeds, specifically duodenal feeds, may be used to bypass the stomach and directly feed the duodenum decreasing the amount of gastric reflux contributing to aspiration. Duodenal feeds are equivalent to gastric feeds with regards to nutritional outcomes, and have been shown to decrease events of apnea and bradycardia in premature infants. This study will evaluate the feasibility and safety of duodenal feeds in premature infants. The hypothesis is that duodenal feeds may be safely and successfully performed in premature very low birth weight infants.
Detailed description
The primary outcome of this study is the safety and feasibility of duodenal feeds in very low birth weight infants. The secondary outcomes are various measures related to growth, respiratory support, comorbidities, and hospitalization.
Eligibility of infants admitted to the Johns Hopkins All Children's Neonatal Intensive Care Unit (NICU) will be determined based on inclusion and exclusion criteria. Eligible infants will be recruited and enrolled by 14 days of life after informed consent is obtained. Randomization of the infants into two groups- investigational continuous Duodenal Feeds (DF) or standard Gastric Feeds (GF) - will occur just prior to the infants advancing beyond 50mL/kg/day of enteral feeds.
All enrolled infants will be fed per the institutional feeding protocol. Once infants advance past 50mL/kg/day of enteral feeds, at this point infants will be randomized to DF or GF groups in a 1:1 block randomization using blinded envelopes. Multiple gestation infants will be randomized individually.
Placement of gastric tubes will be per standard of practice, and insertion of duodenal tube will be per manual of operations. Continuous duodenal feeds will be provided over 24 hours as a continuous infusion through a nasoduodenal or oro-duodenal tube. Standard gastric feeds will be infused via a nasogastric or orogastric tube per the instructions of the medical team. Gastric feeds are provided as standard of care in the NICU; intermittent bolus feeds over 15-60 minutes. Feeding time may be prolonged by the medical team, for longer than 60 minutes and possibly even be given continuously, for various reasons (emesis, reflux, apnea, bradycardia, etc.) and will be monitored and recorded. Feed volume and advancement will continue to be determined by standardized institutional feeding guidelines. Decision to provide further fortification of feeds beyond institutional guidelines will be determined by the medical team and not standardized in this protocol. Once full enteral feeds are achieved (total fluid goal of at least 140mL/kg/day), patients will continue to receive feeds via the designated route.
An institutional "Infant Driven Feeding Guideline" is utilized to evaluate readiness to orally feed and to transition premature infants from enteral to oral feeds. Once an infant is eligible to receive oral feeds per this guideline (32 weeks postmenstrual age, and tolerating ≤2L flow via nasal cannula for at least 24 hours), the study will allow the medical team to transition infants in the DF group to gastric feeds. Regarding transitioning infant from duodenal to gastric feeds, infants are initially placed on continuous gastric feeds, and once the participants have demonstrated tolerance (no evidence of reflux, increased respiratory support, emesis), the participants are then transitioned to bolus gastric feeds progressively. Infants may be allowed to orally feed during this transition period if the participants meet the appropriate infant driven feeding scores per protocol.
All infants in this study will be monitored for primary and secondary outcomes through the duration of admission and up until the time of discharge. Safety events will be frequently monitored for throughout the duration of admission and addressed immediately if warranted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Feeds | No intervention | –Patients in this arm will receive feeds via the standard route which is gastric feeds. |
| Duodenal Feeds | Experimental | Other: Mode of Delivery of FeedsPatients in this arm will receive feeds via the experimental route which is duodenal feeds. |
Who may qualify
- Ages
- 0 days to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants admitted to the Johns Hopkins All Children's NICU before 72 hours of life
- Infants with a birth weight <1251g
Key exclusion criteria (8 listed)
- First obtained pH <7.0
- APGAR <5 at 5 minutes (The Apgar score is a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. Appearance, Pulse, Grimace, Activity, Respiration (APGAR))
- Infants on hydrocortisone for hypotension prior to randomization
- Infants with intrauterine growth restriction (IUGR) defined by birth weight ≤10th percentile for gestational age
- Infants with congenital anomalies, including but not limited to: Chromosomal abnormalities;Structural airway or pulmonary abnormalities (e.g. tracheoesophageal fistulas, cleft palate, congenital pulmonary adenomatous malformation, etc.); Abdominal anomalies requiring surgical interventions (e.g. intestinal atresia, intestinal webs, gastroschisis, omphalocele, anal atresia); Major cardiac anomalies
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 |
|---|---|---|
| Mode of Delivery of FeedsEligible infants will be recruited and enrolled and randomized to either duodenal feeds (DF) or gastric feeds (GF), which will occur just prior to the infants advancing beyond 50mL/kg/day of enteral feeds. All enrolled infants will be fed per our institutional feeding protocol. Once infants advance past a volume of 50mL/kg/day of enteral feeds, at this point infants will be randomized to DF or GF groups. | Other | Duodenal Feeds |
Primary outcome
Number of successful placements of duodenal tubes
Time frame: 12 months
Success to be measured by appropriate placement of the duodenal tube within the duodenum as confirmed by radiographic imaging.
Safety as assessed by number of intestinal perforations
Time frame: 12 months
Safety of duodenal feeds in very low birth weight infants as measured by the number of intestinal perforations secondary to placement of duodenal tube.
20 secondary outcomes
Supplemental oxygen requirement
Time frame: duration of hospitalization, up to 15 months
Number of participants with Bronchopulmonary Dysplasia
Time frame: 15 months
Number of deaths during hospitalization
Time frame: 15 months
Number of days of mechanical ventilation
Time frame: 15 months
Number of participants with late-onset sepsis
Time frame: 15 months
Central line days
Time frame: 15 months
Number of participants with necrotizing enterocolitis
Time frame: 15 months
Number of replaced enteral tubes
Time frame: 15 months
Number of Radiographs related to enteral tube placement
Time frame: 15 months
Weight percentile at 36 weeks postmenstrual age
Time frame: At 36 weeks
Height percentile at 36 weeks postmenstrual age
Time frame: At 36 weeks
Head circumference percentile at 36 weeks postmenstrual age
Time frame: At 36 weeks
Z-scores for weight at 36 weeks postmenstrual age
Time frame: At 36 weeks
Z-scores for height at 36 weeks postmenstrual age
Time frame: At 36 weeks
Z-scores for head circumference at 36 weeks postmenstrual age
Time frame: At 36 weeks
Daily daily weight gain
Time frame: At 36 weeks
Length of stay
Time frame: duration of hospitalization, up to 15 months
Need for excess fortification of feeds
Time frame: 15 months
Use of postnatal dexamethasone
Time frame: 15 months
Use of chronic diuretics
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 11401896Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
- Background: PubMed 23758808Fenton TR, Nasser R, Eliasziw M, Kim JH, Bilan D, Sauve R. Validating the weight gain of preterm infants between the reference growth curve of the fetus and the term infant. BMC Pediatr. 2013 Jun 11;13:92. doi: 10.1186/1471-2431-13-92.
- Background: PubMed 3174313Shennan AT, Dunn MS, Ohlsson A, Lennox K, Hoskins EM. Abnormal pulmonary outcomes in premature infants: prediction from oxygen requirement in the neonatal period. Pediatrics. 1988 Oct;82(4):527-32.
- Background: PubMed 20732945Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
- Background: PubMed 14754982Poets CF. Gastroesophageal reflux: a critical review of its role in preterm infants. Pediatrics. 2004 Feb;113(2):e128-32. doi: 10.1542/peds.113.2.e128.
- Background: PubMed 12235066Omari TI, Barnett CP, Benninga MA, Lontis R, Goodchild L, Haslam RR, Dent J, Davidson GP. Mechanisms of gastro-oesophageal reflux in preterm and term infants with reflux disease. Gut. 2002 Oct;51(4):475-9. doi: 10.1136/gut.51.4.475.
- Background: PubMed 25318633Garland JS, Alex CP, Johnston N, Yan JC, Werlin SL. Association between tracheal pepsin, a reliable marker of gastric aspiration, and head of bed elevation among ventilated neonates. J Neonatal Perinatal Med. 2014 Jan 1;7(3):185-92. doi: 10.3233/NPM-14814020.
- Background: PubMed 12183728Peter CS, Wiechers C, Bohnhorst B, Silny J, Poets CF. Influence of nasogastric tubes on gastroesophageal reflux in preterm infants: a multiple intraluminal impedance study. J Pediatr. 2002 Aug;141(2):277-9. doi: 10.1067/mpd.2002.126298.
- Background: PubMed 2380892Jolley SG, Halpern CT, Sterling CE, Feldman BH. The relationship of respiratory complications from gastroesophageal reflux to prematurity in infants. J Pediatr Surg. 1990 Jul;25(7):755-7. doi: 10.1016/s0022-3468(05)80012-0.
- Background: PubMed 16954956Farhath S, Aghai ZH, Nakhla T, Saslow J, He Z, Soundar S, Mehta DI. Pepsin, a reliable marker of gastric aspiration, is frequently detected in tracheal aspirates from premature ventilated neonates: relationship with feeding and methylxanthine therapy. J Pediatr Gastroenterol Nutr. 2006 Sep;43(3):336-41. doi: 10.1097/01.mpg.0000232015.56155.03.
- Background: PubMed 15371091Knight PR, Davidson BA, Nader ND, Helinski JD, Marschke CJ, Russo TA, Hutson AD, Notter RH, Holm BA. Progressive, severe lung injury secondary to the interaction of insults in gastric aspiration. Exp Lung Res. 2004 Oct-Nov;30(7):535-57. doi: 10.1080/01902140490489162.
- Background: PubMed 8496756Blondheim O, Abbasi S, Fox WW, Bhutani VK. Effect of enteral gavage feeding rate on pulmonary functions of very low birth weight infants. J Pediatr. 1993 May;122(5 Pt 1):751-5. doi: 10.1016/s0022-3476(06)80021-1.
- Individual participant dataSharing planned: No
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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.
Noura Nickel, MD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mode of Delivery of Feeds in people with BPD - Bronchopulmonary Dysplasia and VLBW - Very Low Birth Weight Infant, run by Johns Hopkins All Children's Hospital 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 2 inclusion and 8 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 18 Mar 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of successful placements of duodenal tubes (time frame: 12 months). 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 NCT04246333, which also lists 28 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 18 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.