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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
November 14, 2017
November 17, 2017
November 17, 2017
December 1, 2018
December 1, 2018   (Final data collection date for primary outcome measure)
Length of high flow nasal cannula (HFNC) therapy [ Time Frame: from the time of hospital admission to discharge (about 3 days) ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Enteral Feeding in Bronchiolitis
  • Device: Nasogastric tube (NGT) feeding
    A nasogastric tube goes from the nose to the stomach.
  • Device: Nasoduodenal tube (NDT) feeding
    A nasoduodenal tube goes from the nose to the duodenum.
  • Active Comparator: nasogastric tube (NGT) feeding
    Intervention: Device: Nasogastric tube (NGT) feeding
  • Active Comparator: nasoduodenal tube (NDT) feeding
    Intervention: Device: Nasoduodenal tube (NDT) feeding
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
250
December 1, 2018
December 1, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 12 Months   (Child)
No
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
United States
 
 
NCT03346850
HSC-MS-17-0725
Not Provided
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
Not Provided
Raymond Parlar-Chun, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Raymond Parlar-Chun, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP