Postpyloric feedings to improve lung health in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate whether postpyloric feedings can enhance pulmonary health in preterm infants suffering from bronchopulmonary dysplasia compared to traditional nasogastric feedings. It employs a randomized controlled crossover design, where each participant will experience both feeding methods in separate blocks. The study will assess clinical outcomes and biomarkers to determine the effectiveness of the feeding approach in reducing lung disease severity. By focusing on high-risk infants, the research seeks to optimize nutritional management and improve overall respiratory outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Jonathan Levin, MD — Boston Children's Hospital
• Study coordinator: Jonathan Levin, MD
• Email: jonathan.levin@childrens.harvard.edu
• Phone: 617-355-1900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.