Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
Primary Purpose
Enteral Feeding in Bronchiolitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasogastric tube (NGT) feeding
Nasoduodenal tube (NDT) feeding
Sponsored by
About this trial
This is an interventional other trial for Enteral Feeding in Bronchiolitis
Eligibility Criteria
Inclusion Criteria:
- All admitted patients for bronchiolitis requiring high flow nasal cannula therapy at Children's Memorial Hermann
Exclusion Criteria:
- Patients with craniofacial abnormalities that prevent tube placement.
- Patients requiring CPAP and mechanical ventilation are also excluded from the study.
- Patients with past surgeries compromising esophageal sphincter tone such as fundoplication or congenital diaphragmatic hernia surgery are excluded.
- Patients transferred to and from PICU are also excluded from the study.
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
nasogastric tube (NGT) feeding
nasoduodenal tube (NDT) feeding
Arm Description
Outcomes
Primary Outcome Measures
Length of Respiratory Supprt
Secondary Outcome Measures
Number of Participants With Emesis
Peak Respiratory Support in Liters Per Minute
Number of Chest X-rays Obtained Among All Participants
Number of Participants Who Revisited the Emergency Room (ER)
Number of Participants Who Revisited the Emergency Room (ER)
Number of Participants Who Were Readmitted to the Hospital
Number of Participants Who Were Readmitted to the Hospital
Full Information
NCT ID
NCT03346850
First Posted
November 14, 2017
Last Updated
March 9, 2020
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03346850
Brief Title
Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
Official Title
Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Loss of equipoise among enrolling clinicians, as well as emergence of external literature showing safety of nasogastric tube (NGT) feeds.
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of the study is to compare two ways (nasogastric tube (NGT) and nasoduodenal tube (NDT)) to provide nutrition to infants admitted to the hospital for viral bronchiolitis and who require high flow nasal cannula therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Feeding in Bronchiolitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nasogastric tube (NGT) feeding
Arm Type
Active Comparator
Arm Title
nasoduodenal tube (NDT) feeding
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Nasogastric tube (NGT) feeding
Intervention Description
A nasogastric tube goes from the nose to the stomach.
Intervention Type
Device
Intervention Name(s)
Nasoduodenal tube (NDT) feeding
Intervention Description
A nasoduodenal tube goes from the nose to the duodenum.
Primary Outcome Measure Information:
Title
Length of Respiratory Supprt
Time Frame
from the time of hospital admission to discharge (about 6 days)
Secondary Outcome Measure Information:
Title
Number of Participants With Emesis
Time Frame
from the time of hospital admission to discharge (about 6 days)
Title
Peak Respiratory Support in Liters Per Minute
Time Frame
from the time of hospital admission to discharge (about 6 days)
Title
Number of Chest X-rays Obtained Among All Participants
Time Frame
from the time of hospital admission to discharge (about 6 days)
Title
Number of Participants Who Revisited the Emergency Room (ER)
Time Frame
7 days after discharge from hospital
Title
Number of Participants Who Revisited the Emergency Room (ER)
Time Frame
30 days after discharge from hospital
Title
Number of Participants Who Were Readmitted to the Hospital
Time Frame
7 days after discharge from initial hospital visit
Title
Number of Participants Who Were Readmitted to the Hospital
Time Frame
30 days after discharge from initial hospital visit
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- All admitted patients for bronchiolitis requiring high flow nasal cannula therapy at Children's Memorial Hermann
Exclusion Criteria:
Patients with craniofacial abnormalities that prevent tube placement.
Patients requiring CPAP and mechanical ventilation are also excluded from the study.
Patients with past surgeries compromising esophageal sphincter tone such as fundoplication or congenital diaphragmatic hernia surgery are excluded.
Patients transferred to and from PICU are also excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Parlar-Chun, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31061025
Citation
Parlar-Chun R, Lafferty-Prather M, Gonzalez V, Pedroza C, Gourishankar A. Protocol: randomised trial to compare nasoduodenal tube and nasogastric tube feeding in infants with bronchiolitis on high-flow nasal cannula; Bronchiolitis and High-flow nasal cannula with Enteral Tube feeding Randomised (BHETR) trial. BMJ Open. 2019 May 5;9(5):e025405. doi: 10.1136/bmjopen-2018-025405.
Results Reference
derived
Learn more about this trial
Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
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