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Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
A Randomized Controlled Crossover Trial of Postpyloric Versus Gastric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
Who can join
0 Hours – 1 Year · All sexes
Full eligibility criteria
Inclusion Criteria: Preterm infants born \< 32 weeks' gestation may enroll at 34-44 weeks post-menstrual age, who: 1. Remain on either invasive ventilation or non-invasive ventilation (continuous positive airway pressure or nasal intermittent positive pressure ventilation) for minimum 48 hours at the time of study entry. The minimum support required for inclusion is CPAP \> 5cm H2O or CPAP 5 with FiO2 \> 21%. 2. Have ongoing need for respiratory support due to underlying lung disease from prematurity. 3. Are tolerating \> 80 ml/kg/day of enteral feedings at baseline, either via nasogastric (NG) or nasojejunal (NJ) tube. Patients may be receiving gastric (NG) or postpyloric (NJ) feedings. Exclusion Criteria: 1. Infants who are transiently on respiratory support at the time of study entry due to another reason than underlying lung disease from prematurity; for example, recovery from a surgical intervention. 2. Infants who have other comorbidities that significantly contribute to lung disease, including cyanotic congenital heart disease, or other genetic, congenital, or pulmonary abnormalities. 3. Infants who were evaluated for necrotizing enterocolitis (including holding feedings) in the 7 days prior to study enrollment. 4. Infants with known gastrointestinal or airway malformations that would affect tolerance of feeds or the route of delivery of enteral feedings.
About the study
The purpose of this study is to determine if postpyloric feedings effectively improve objective measures of pulmonary health in preterm infants with chronic lung disease when compared with nasogastric (NG) feedings. This research will (1) determine the optimal nutritional management to prevent a common and costly complication of prematurity, and (2) use a novel crossover design that examines outcomes of clinical endpoints alongside biomarkers.
What is being tested
- Gastric Feeds (procedure)
- Jejunal Feeds (procedure)
Sponsor: Boston Children's Hospital · Participants: 50 · Started: Apr 26, 2024
Contact the study team
- Jonathan Levin, MD · Phone: 617-355-1900
- Vanessa J Young, MS · Phone: 617-355-8330
Official record on ClinicalTrials.gov — NCT05777512
Locations in the U.S.
| Massachusetts | Boston Children's Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.