Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-12
SponsorChildren's Hospital of Philadelphia
About this trial
The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature who have been diagnosed with bronchopulmonary dysplasia. The main questions this trial aims to answer are:
Does transpyloric as compared to gastric tube feeding result in differences in the amount of experienced hypoxemia (low oxygen level in the blood) or serious adverse events?
Does transpyloric as compared to gastric tube feeding reduce the frequency and severity of gastroesophageal reflux (GER) measured using 24 hour esophageal pH-multichannel intraluminal impedance (pH-MII) monitoring?
Participants will:
Undergo pre-trial 24 hour pH-MII monitoring to determine baseline severity of GER.
Be randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks.
Undergo repeat pH-MII at the end of the 2 week trial to assess for change in GER.
Undergo continuous pulse oximetry to record level of hypoxemia during the 2 week trial.
Undergo saliva and airway (if supported by a breathing tube) fluid collection to measure biomarkers of GER.
Be monitored clinically for possible adverse events.
Eligibility criteria
Qualifiers
Birth <32 weeks' gestation
Current postmenstrual age of 36-65 weeks
Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L/min flow nasal cannular at 36 weeks' PMA) with subsequent need for prolonged positive airway pressure and full enteral tube feedings
Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment
Disqualifiers
Transpyloric feedings received within 7d of enrollment
Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment
History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding
Plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial
Trial design
Treatments tested in this trial
- Transpyloric tube feeding
- Gastric tube feeding
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Lucile Packard Children's Hospital
Collaborator
Source ClinicalTrials.gov