Transpyloric vs Gastric Feeding for Bronchopulmonary Dysplasia

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Children's Hospital of Philadelphia

No Placebo Group

Trial Summary

What is the purpose of 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

This trial is for premature infants with bronchopulmonary dysplasia and acid reflux. Infants must have a baseline level of gastroesophageal reflux measured before the trial. They cannot participate if they have conditions that would make the feeding methods unsafe or if their health status could interfere with the study's procedures.

Inclusion Criteria

Parental consent to participate

I am using a device to help with my breathing at the time of joining.

Birth <32 weeks' gestation

+3 more

Exclusion Criteria

I have received nutrition through a tube past my stomach within the last week.

Active treatment with an investigational therapy as part of another interventional trial

I have a severe birth defect affecting my heart, lungs, or digestion.

+5 more

Participant Groups

The study compares two ways of feeding infants: transpyloric tube feeding (directly into the small intestine) versus gastric tube feeding (into the stomach). It aims to see which method better reduces acid reflux and low oxygen levels in blood, using monitoring techniques over a 2-week period.

2Treatment groups

Experimental Treatment

Group I: Transpyloric tube feedingExperimental Treatment1 Intervention

Nasal or oral placed feeding tube with the distal end located within the second or third portion of the duodenum. Correct placement confirmed by radiograph.

Group II: Gastric tube feedingExperimental Treatment1 Intervention

Nasal or oral placed feeding tube with distal end located within the stomach. Correct placement confirmed by point of care aspirate pH testing or radiograph based on local clinical standard.