Postpyloric feedings to improve lung health in preterm infants
A Randomized Controlled Crossover Trial of Postpyloric Versus Gastric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
This study is testing if feeding preterm infants directly into their intestines can help improve their lung health better than regular feeding through the nose.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 0 Hours to 1 Year |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05777512 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born before 32 weeks' gestation who require respiratory support and are tolerating enteral feedings.
Not a fit: Patients who are on temporary respiratory support for reasons unrelated to lung disease from prematurity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pulmonary health and reduced complications for preterm infants with chronic lung disease.
How similar studies have performed: While the approach of using postpyloric feedings is innovative, similar studies have not been widely conducted, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.