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Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants

United States50 participantsStarted 2024-10

Plain-language 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.

Who can participate

Age range0 Hours – 1 Year

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Change in modified respiratory severity score (mRSS)

Timeframe: Over a 15 day period during study participation

Tracheal Aspirates

Timeframe: Over a 15 day period during study participation.

Trial details

NCT IDNCT05777512

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09

Contact for this trial

Jonathan Levin, MD

617-355-1900 jonathan.levin@childrens.harvard.edu

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