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Trial record 2 of 259383 for:    ALL

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

This study is not yet open for participant recruitment.
Verified November 2017 by Raymond Parlar-Chun, The University of Texas Health Science Center, Houston
Sponsor:
ClinicalTrials.gov Identifier:
NCT03346850
First Posted: November 17, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Raymond Parlar-Chun, The University of Texas Health Science Center, Houston
  Purpose
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.

Condition Intervention
Enteral Feeding in Bronchiolitis Device: Nasogastric tube (NGT) feeding Device: Nasoduodenal tube (NDT) feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula

Further study details as provided by Raymond Parlar-Chun, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Length of high flow nasal cannula (HFNC) therapy [ Time Frame: from the time of hospital admission to discharge (about 3 days) ]

Secondary Outcome Measures:
  • Number of emesis [ Time Frame: from the time of hospital admission to discharge (about 3 days) ]
  • Peak respiratory support in liters per minute [ Time Frame: from the time of hospital admission to discharge (about 3 days) ]
  • Number of x-rays obtained [ Time Frame: from the time of hospital admission to discharge (about 3 days) ]
  • Emergency room (ER) revisit [ Time Frame: 30 days after discharge from hospital ]
  • Hospital readmission [ Time Frame: 30 days after discharge from initial hospital visit ]

Estimated Enrollment: 250
Anticipated Study Start Date: December 1, 2018
Estimated Study Completion Date: December 1, 2018
Estimated Primary Completion Date: December 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346850


Contacts
Contact: Raymond Parlar-Chun, MD (713) 500-5666 Raymond.L.Chun@uth.tmc.edu
Contact: Anand Gourishankar, MD (713) 500-5666 Anand.Gourishankar@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Raymond Parlar-Chun, MD    713-500-5666    Raymond.L.Chun@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Raymond Parlar-Chun, MD The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Raymond Parlar-Chun, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03346850     History of Changes
Other Study ID Numbers: HSC-MS-17-0725
First Submitted: November 14, 2017
First Posted: November 17, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections