Recruiting

Postpyloric Feedings

Sponsor:

Boston Children's Hospital

Code:

NCT05777512

Conditions

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Gastric Feeds

Jejunal Feeds

Study Details

Brief summary:

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.

Conditions

Bronchopulmonary Dysplasia

Study ID

NCT05777512

Start date

Apr 26, 2024

Status verified date

Jun, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group A: Gastric Followed by Jejunal 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.

experimental: Group B: Jejunal Followed by Gastric 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.

Interventions

Gastric Feeds

The participant will receive nutrition via a nasogastric tube. Gastric feedings will be administered as bolus feeds every 3 hours over 1 hour. Infants who are deemed able to advance oral feedings via mouth during the study period will be permitted to do so, and this will be recorded.

Jejunal Feeds

The participant will receive nutrition via a nasojejunal tube. Postpyloric feedings will be administered continuously into the jejunum. Infants who are deemed able to advance oral feedings via mouth during the study period will be permitted to do so, and this will be recorded.

Primary outcome measure

  • Change in modified respiratory severity score (mRSS) [ Time Frame: Over a 15 day period during study participation ]
  • Tracheal Aspirates [ Time Frame: Over a 15 day period during study participation. ]

Central Contacts and Locations

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Chronic Lung Disease of Prematurity
  • Postpyloric Feeding
  • Nasojejunal Feeding
  • Bronchopulmonary Dysplasia
  • GERD
  • Gastro-esophageal Reflux

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-06-29.