NCT04480970

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 22, 2023

Status Verified

July 1, 2022

Enrollment Period

3.7 years

First QC Date

July 17, 2020

Last Update Submit

February 21, 2023

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • Respiratory status

    A bronchiolitis scoring tool, the Marlais Risk of Admission Score, will be used to assess the respiratory status of patients. This tool includes the following components: respiratory rate, oxygen saturation, heart rate, age, and length of illness.

    60 minutes

Study Arms (1)

Nasogastric tube placement

EXPERIMENTAL
Device: Nasogastric tube placement

Interventions

Nasogastric tube placementDEVICE

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

Nasogastric tube placement

Eligibility Criteria

Age1 Day - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • David Spiro, MD, MPH

    AR Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leroy Crawley, MS

CONTACT

5013643481crawleylj@archildrens.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

August 3, 2020

Primary Completion

April 1, 2024

Study Completion

July 1, 2025

Last Updated

February 22, 2023

Record last verified: 2022-07

Locations

US(1)