Transpyloric Feeding in Severe Bronchopulmonary Dysplasia
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/7/2018 |
| Start Date: | December 18, 2014 |
| End Date: | July 15, 2016 |
Pilot N-of-1 Multiple Crossover Randomized Trial of Gastric and Transpyloric Feeds in Infants With 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 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.
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.
Inclusion Criteria:
- Gestational age ≤ 32 weeks
- Severe BPD (FiO2 ≥ 30% and/or mechanical ventilation or non-invasive positive pressure
respiratory support at the time of enrollment)
- Post menstrual age of 36-45 6/7 weeks at enrollment
- Parent and/or guardian permission (informed consent)
Exclusion Criteria:
- Prior intolerance to transpyloric feeds
- History of surgical anti-reflux procedure
- Congenital heart disease (not including patent ductus arterioles and hemodynamically
insignificant ventricular septal defect or atrial septal defect)
- Structural abnormalities of the upper airway, lungs, or chest wall
- Other congenital malformations or syndromes that adversely affect life expectancy or
cardio-pulmonary development
- Parent, guardian, or subject who, in the opinion of the investigators, are unlikely to
participate for the duration of the study
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 267-648-2720
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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