Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula

March 9, 2020 updated by: Raymond Parlar-Chun, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: nasogastric tube (NGT) feeding
Device: Nasogastric tube (NGT) feeding
A nasogastric tube goes from the nose to the stomach.
ACTIVE_COMPARATOR: nasoduodenal tube (NDT) feeding
Device: Nasoduodenal tube (NDT) feeding
A nasoduodenal tube goes from the nose to the duodenum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of Respiratory Supprt
Time Frame: from the time of hospital admission to discharge (about 6 days)
from the time of hospital admission to discharge (about 6 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Emesis
Time Frame: from the time of hospital admission to discharge (about 6 days)
from the time of hospital admission to discharge (about 6 days)
Peak Respiratory Support in Liters Per Minute
Time Frame: from the time of hospital admission to discharge (about 6 days)
from the time of hospital admission to discharge (about 6 days)
Number of Chest X-rays Obtained Among All Participants
Time Frame: from the time of hospital admission to discharge (about 6 days)
from the time of hospital admission to discharge (about 6 days)
Number of Participants Who Revisited the Emergency Room (ER)
Time Frame: 7 days after discharge from hospital
7 days after discharge from hospital
Number of Participants Who Revisited the Emergency Room (ER)
Time Frame: 30 days after discharge from hospital
30 days after discharge from hospital
Number of Participants Who Were Readmitted to the Hospital
Time Frame: 7 days after discharge from initial hospital visit
7 days after discharge from initial hospital visit
Number of Participants Who Were Readmitted to the Hospital
Time Frame: 30 days after discharge from initial hospital visit
30 days after discharge from initial hospital visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (ACTUAL)

November 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-17-0725

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Enteral Feeding in Bronchiolitis

Clinical Trials on Nasogastric tube (NGT) feeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe