Transpyloric Feeding in Severe Bronchopulmonary Dysplasia
Primary Purpose
Bronchopulmonary Dysplasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transpyloric feeding
gastric feeding
Sponsored by
About this trial
This is an interventional treatment trial for Bronchopulmonary Dysplasia
Eligibility Criteria
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
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
transpyloric tube feeds
gastric tube feeds
Arm Description
Continuous transpyloric tube feeds administered through an oral/nasal feeding tube.
Continuous gastric tube feeds administered through an oral/nasal feeding tube.
Outcomes
Primary Outcome Measures
Change in transient intermittent hypoxemic events every 4 days
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02142621
First Posted
May 15, 2014
Last Updated
February 2, 2018
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT02142621
Brief Title
Transpyloric Feeding in Severe Bronchopulmonary Dysplasia
Official Title
Pilot N-of-1 Multiple Crossover Randomized Trial of Gastric and Transpyloric Feeds in Infants With Severe Bronchopulmonary Dysplasia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 18, 2014 (Actual)
Primary Completion Date
July 15, 2016 (Actual)
Study Completion Date
July 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
The investigators hypothesize that transpyloric compared to gastric feeds will be associated overall with a 15% reduction in number of daily intermittent hypoxemic events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transpyloric tube feeds
Arm Type
Active Comparator
Arm Description
Continuous transpyloric tube feeds administered through an oral/nasal feeding tube.
Arm Title
gastric tube feeds
Arm Type
Active Comparator
Arm Description
Continuous gastric tube feeds administered through an oral/nasal feeding tube.
Intervention Type
Other
Intervention Name(s)
transpyloric feeding
Intervention Type
Other
Intervention Name(s)
gastric feeding
Primary Outcome Measure Information:
Title
Change in transient intermittent hypoxemic events every 4 days
Description
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.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
24 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haresh Kirpalani, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31685527
Citation
Jensen EA, Zhang H, Feng R, Dysart K, Nilan K, Munson DA, Kirpalani H. Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):399-404. doi: 10.1136/archdischild-2019-317148. Epub 2019 Nov 4.
Results Reference
derived
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Transpyloric Feeding in Severe Bronchopulmonary Dysplasia
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