NCT05777512 · Boston Children's Hospital
Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Preterm infants born \< 32 weeks' gestation may enroll at 34-44 weeks post-menstrual age, who:
- 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.
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations