Clinical trial NCT03346850: 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
Overall status: TERMINATED
Phase: NA
Conditions: Enteral Feeding in Bronchiolitis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 40
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Length of Respiratory Supprt
timeFrame: from the time of hospital admission to discharge (about 6 days)
Secondary outcomes:
measure: Number of Participants With Emesis
timeFrame: from the time of hospital admission to discharge (about 6 days)
measure: Peak Respiratory Support in Liters Per Minute
timeFrame: from the time of hospital admission to discharge (about 6 days)
measure: Number of Chest X-rays Obtained Among All Participants
timeFrame: from the time of hospital admission to discharge (about 6 days)
measure: Number of Participants Who Revisited the Emergency Room (ER)
timeFrame: 7 days after discharge from hospital
measure: Number of Participants Who Revisited the Emergency Room (ER)
timeFrame: 30 days after discharge from hospital
measure: Number of Participants Who Were Readmitted to the Hospital
timeFrame: 7 days after discharge from initial hospital visit
measure: Number of Participants Who Were Readmitted to the Hospital
timeFrame: 30 days after discharge from initial hospital visit
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Raymond Parlar-Chun, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.