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NCT02142621 · ClinicalTrials.gov registry record · NA
Transpyloric Feeding in Severe Bronchopulmonary Dysplasia
A NA study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT02142621: Completed NA study, sponsored by Children's Hospital of Philadelphia.
NCT02142621 is a NA study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02142621, a NA study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
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. T
Primary Outcome
transient hypoxemic events is defined for the purposes of this study as an oxygen saturation \< 80% for ≥ 10 seconds and \< 3 minutes recorded by continuous pulse oximetry.
Interventions
- OTHER transpyloric feeding
- OTHER gastric feeding
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-12-18 |
| Est. Completion | 2016-07-15 |
| Phase | NA |
What the finished NCT02142621 record still lists
NCT02142621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which transpyloric feeding is the first listed.
NCT02142621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02142621 about?
NCT02142621 is a clinical study titled "Transpyloric Feeding in Severe Bronchopulmonary Dysplasia". 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 cardiopulmon...
What is the current status of trial NCT02142621?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2014-12-18. Estimated completion is 2016-07-15.
What interventions are being tested in trial NCT02142621?
The interventions under investigation include: transpyloric feeding (OTHER), gastric feeding (OTHER).
Who is sponsoring clinical trial NCT02142621?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02142621's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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