Recruiting

Observational Study

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT04480970

Conditions

Bronchiolitis

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Interventions

Nasogastric tube placement

Study Details

Brief summary:

This study aims to evaluate whether placing nasogastric tubes for gastric decompression improves respiratory distress for patients with bronchiolitis who are receiving oxygen via high-flow nasal cannula.

Conditions

Bronchiolitis

Study ID

NCT04480970

Start date

Aug 3, 2020

Status verified date

Jul, 2022

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Apr 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Diagnosis of bronchiolitis by the attending physician
  • On high flow nasal cannula (4 liters or greater)
  • Ages 0 months to 23 months

Exclusion Criteria:

  • Diagnosis of bacterial pneumonia
  • History of cranio-facial anomalies
  • History of congenital heart disease
  • History of G-tube dependence
  • History of short gut syndrome
  • History of tracheostomy or current tracheostomy

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nasogastric tube placement

Interventions

Nasogastric tube placement

All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.

Primary outcome measure

  • Respiratory status [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Leroy Crawley, MS

5013643481crawleylj@archildrens.org

Locations

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Leroy Crawley, MS

501-364-3481crawleylj@archildrens.org

David Spiro, MD, MPH

5013641050dmspiro@uams.edu

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Feb 22, 2023

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2023-02-22.