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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03346850
Recruitment Status : Terminated (Loss of equipoise among enrolling clinicians, as well as emergence of external literature showing safety of nasogastric tube (NGT) feeds.)
First Posted : November 17, 2017
Results First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Raymond Parlar-Chun, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Enteral Feeding in Bronchiolitis Device: Nasogastric tube (NGT) feeding Device: Nasoduodenal tube (NDT) feeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

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.




Primary Outcome Measures :
  1. Length of Respiratory Supprt [ Time Frame: from the time of hospital admission to discharge (about 6 days) ]

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


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.

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


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Raymond Parlar-Chun, MD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Raymond Parlar-Chun, The University of Texas Health Science Center, Houston:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raymond Parlar-Chun, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03346850    
Other Study ID Numbers: HSC-MS-17-0725
First Posted: November 17, 2017    Key Record Dates
Results First Posted: March 25, 2020
Last Update Posted: March 25, 2020
Last Verified: March 2020

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