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Clinical trialNCT02142621CompletedInterventional

Transpyloric Feeding in Severe Bronchopulmonary Dysplasia

SponsorChildren's Hospital of PhiladelphiaEnrollment15Bronchopulmonary Dysplasia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth. It impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants with birth weight \< 1000g. BPD is associated with multiple long-term adverse outcomes including chronic cardiopulmonary and neurodevelopmental impairments. Infants with severe BPD, defined as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36 weeks postmenstrual age (PMA), suffer the greatest burden of these chronic sequelae. Recurrent episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to the development of these impairments. Gastroesophageal reflux (GER) contributes to these mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. Unfortunately, clinically available methods to diagnose GER in infants are unreliable. Moreover, acid suppressive agents are both ineffective and carry high risk of serious life-threatening morbidity. Simple transpyloric feeding has promise, but has not been evaluated in BPD. This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway complications of GER and and whether this methodology can aid in identifying individual infants with severe BPD who are likely to benefit from prolonged use of transpyloric feeds. Aim 1. To determine for each enrolled infant with severe BPD whether transpyloric compared to gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome) and improve a validated BPD severity score (secondary outcome). The investigators hypothesize that 80% percent of enrolled infants will have significantly fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and will have this feeding method formally recommended. Aim 2. To pool results from multiple N-of-1 trials to determine whether transpyloric compared to gastric feeds reduce airway complications of GER in infants with severe BPD. The investigators hypothesize that transpyloric compared to gastric feeds will be associated overall with a 15% reduction in number of daily intermittent hypoxemic events.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • the Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
18 Dec 2014
Primary completion
15 Jul 2016
Completion
15 Jul 2016
Last update posted
5 Feb 2018
Registered enrollment
15
Registry id
NCT02142621

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.