BronchiolitisNCT04480970
Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis
A study testing Nasogastric tube placement in people with Bronchiolitis, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 1 day to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Nasogastric tube placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of bronchiolitis by the attending physician
- On high flow nasal cannula (4 liters or greater)
- Ages 0 months to 23 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Leroy Crawley, MS, 501-364-3481, crawleylj@archildrens.org
David Spiro, MD, MPH, 5013641050, dmspiro@uams.edu
About this study
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.
- Conditions
- Bronchiolitis
- Being tested
- Nasogastric tube placement
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric tube placementDevice
All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric tube placement | Experimental | Not described Receives: Device: Nasogastric tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start3 Aug 2020
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Spiro, MD, MPH, Principal investigator, AR Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480970
- Sponsor's protocol ID
- IRB 261122
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis
- ClinicalTrials.gov ID
- NCT04480970
- Acronym / sponsor ID
- IRB 261122
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasogastric tube placement | Experimental | Device: Nasogastric tube placement |
Who may qualify
- Ages
- 1 day to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of bronchiolitis by the attending physician
- On high flow nasal cannula (4 liters or greater)
- Ages 0 months to 23 months
Key exclusion criteria (6 listed)
- Diagnosis of bacterial pneumonia
- History of cranio-facial anomalies
- History of congenital heart disease
- History of G-tube dependence
- History of short gut syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasogastric tube placementAll patients enrolled in the study will have a nasogastric tube placed for gastric decompression. | Device | Nasogastric tube placement |
Primary outcome
Respiratory status
Time frame: 60 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spiro, MD, MPH principal investigator
AR Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasogastric tube placement in people with Bronchiolitis, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leroy Crawley, MS (5013643481, crawleylj@archildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory status (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.