NCT02142621

Transpyloric Feeding in Severe Bronchopulmonary Dysplasia

Completed NA Last updated 5 February 2018

What this trial tests

NA trial testing transpyloric feeding in Bronchopulmonary Dysplasia in 15 participants. Completed in 15 July 2016.

Timeline

18 December 2014

Primary endpoint
15 July 2016

15 July 2016

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	18 December 2014
Primary completion	15 July 2016
Estimated completion	15 July 2016
Sites	1 location across United States

Drugs / interventions tested

• transpyloric feeding
• gastric feeding

Conditions studied

• Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 4 Weeks to 24 Weeks, any sex, with Bronchopulmonary Dysplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding.
   Jensen EA, Zhang H, Feng R, Dysart K, et al · · 2020 · cited 18× · PMID 31685527 · DOI 10.1136/archdischild-2019-317148