NCT05777512 Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
| NCT ID | NCT05777512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-04-26 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Jonathan Levin, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT05777512 clinical trial?
This trial is open to participants of all sexes, aged 0 Hours or older, up to 1 Year, studying Bronchopulmonary Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05777512 currently recruiting?
Yes, NCT05777512 is actively recruiting participants. Contact the research team at jonathan.levin@childrens.harvard.edu for enrollment information.
Where is the NCT05777512 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05777512 clinical trial?
NCT05777512 is sponsored by Boston Children's Hospital. The principal investigator is Jonathan Levin, MD at Boston Children's Hospital. The trial plans to enroll 50 participants.