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Status unknownNCT04480970Updated Feb 22, 2023

Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis

An interventional study of Nasogastric tube placement in Bronchiolitis, sponsored by Arkansas Children's Hospital Research Institute. Status unknown at 1 site in United States. Open to participants aged 1 Day to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-22.

Sponsored by Arkansas Children's Hospital Research Institute · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
1 Day to 23 Months
Sex
All
01

Study 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.

Read the detailed description

All patients will be consented per IRB procedure. The study will be a prospective study. Study participants will be enrolled after placement on high flow nasal cannula. The respiratory therapist or study staff will use a bronchiolitis scoring tool, the Marlais Risk of Admission Score, to assess the respiratory status of patients after placement on high flow nasal cannula, and prior to placement of NG tube to establish a baseline measurement. This tool includes the following components: respiratory rate, oxygen saturation, heart rate, age, and length of illness. An NG tube will then be placed. Thirty minutes and sixty minutes after placement of the NG tube, the respiratory therapist or study team will again use this scoring tool to assess the respiratory status of the patient. After 60 minutes the study will be concluded. As subject will be requiring oxygen use, admission to an inpatient unit is required. The NG tube will be removed at the discretion of the provider or the admitting physician, who may choose to keep it in at their discretion.

02

Conditions studied

  • Bronchiolitis

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03

In context

Bronchiolitis

365 studies on the registry are indexed under Bronchiolitis; 45 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 251 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Arkansas Children's Hospital Research Institute is the lead sponsor of 122 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 23 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Nasogastric tube placement

    Device: Nasogastric tube placement

Interventions

  • DeviceNasogastric tube placement

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

06

What researchers measure

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.

    Time frame: 60 minutes

07

Study locations

1 of 1 sites recruiting
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2020 (actual). Primary completion is estimated for Apr 2024, 43 months after the start.

Of 58 non-industry interventional studies with no phase under Bronchiolitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 43 months is above that.

Counting every sponsor, half of 60 studies reached it within 15 months; a quarter within 10 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2020
First posted
Jul 22, 2020
StartActual
Aug 3, 2020
Primary completionEst.
Apr 1, 2024
CompletionEst.
Jul 1, 2025
Last update
Feb 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04480970
Responsible party
Sponsor
First posted
Jul 22, 2020
Start date
Aug 3, 2020
Primary completion
Apr 1, 2024 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Feb 22, 2023

Study contacts

Leroy Crawley, MS
Contact
crawleylj@archildrens.org
5013643481
David Spiro, MD, MPH
principal investigator · AR Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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