Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
Bronchopulmonary Dysplasia
About this trial
This is an interventional supportive care trial for Bronchopulmonary Dysplasia focused on measuring Chronic Lung Disease of Prematurity, Postpyloric Feeding, Nasojejunal Feeding, Bronchopulmonary Dysplasia, GERD, Gastro-esophageal Reflux
Eligibility Criteria
Inclusion Criteria: Preterm infants born < 32 weeks' gestation may enroll at 34-44 weeks post-menstrual age, who: 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%. Have ongoing need for respiratory support due to underlying lung disease from prematurity. 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: 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. Infants who have other comorbidities that significantly contribute to lung disease, including cyanotic congenital heart disease, or other genetic, congenital, or pulmonary abnormalities. Infants who were evaluated for necrotizing enterocolitis (including holding feedings) in the 7 days prior to study enrollment. Infants with known gastrointestinal or airway malformations that would affect tolerance of feeds or the route of delivery of enteral feedings.
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A: Gastric Followed by Jejunal Feeds
Group B: Jejunal Followed by Gastric Feeds
Participants randomized into this group will begin with one ten-day block of nasogastric (NG) feeds followed by one ten-day block of nasojejunal (NJ, postpyloric) feeds.
Participants randomized into this group will begin with one ten-day block of nasojejunal (NJ, postpyloric) feeds followed by one ten-day block of nasogastric (NG) feeds.