Enteral Feeding in BronchiolitisNCT03346850
Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
A study testing Nasogastric tube (NGT) feeding and Nasoduodenal tube (NDT) feeding in people with Enteral Feeding in Bronchiolitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Enteral Feeding in Bronchiolitis
- What is being tested?
- Nasogastric tube (NGT) feeding and Nasoduodenal tube (NDT) feeding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All admitted patients for bronchiolitis requiring high flow nasal cannula therapy at Children's Memorial Hermann
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Enteral Feeding in Bronchiolitis
- Being tested
- Nasogastric tube (NGT) feeding, Nasoduodenal tube (NDT) feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric tube (NGT) feedingDevice
A nasogastric tube goes from the nose to the stomach.
Nasoduodenal tube (NDT) feedingDevice
A nasoduodenal tube goes from the nose to the duodenum.
| Study group | Role | What they receive |
|---|---|---|
| nasogastric tube (NGT) feeding | Active comparator | Not described Receives: Device: Nasogastric tube (NGT) feeding |
| nasoduodenal tube (NDT) feeding | Active comparator | Not described Receives: Device: Nasoduodenal tube (NDT) feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Respiratory Supprt
Measured: from the time of hospital admission to discharge (about 6 days)
Secondary outcomes (7)
Number of Participants With Emesis
Measured: from the time of hospital admission to discharge (about 6 days)
Peak Respiratory Support in Liters Per Minute
Measured: from the time of hospital admission to discharge (about 6 days)
Number of Chest X-rays Obtained Among All Participants
Measured: from the time of hospital admission to discharge (about 6 days)
Number of Participants Who Revisited the Emergency Room (ER)
Measured: 7 days after discharge from hospital
Number of Participants Who Revisited the Emergency Room (ER)
Measured: 30 days after discharge from hospital
Number of Participants Who Were Readmitted to the Hospital
Measured: 7 days after discharge from initial hospital visit
Number of Participants Who Were Readmitted to the Hospital
Measured: 30 days after discharge from initial hospital visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Dec 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Why it stopped: Loss of equipoise among enrolling clinicians, as well as emergence of external literature showing safety of nasogastric tube (NGT) feeds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral Feeding in BronchiolitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Parlar-Chun, The University of Texas Health Science Center, Houston
- Investigators
- Raymond Parlar-Chun, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346850
- Sponsor's protocol ID
- HSC-MS-17-0725
- Status last verified
- Mar 2020
- First submitted
- 14 Nov 2017
- Last updated
- 25 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 31061025
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula
- ClinicalTrials.gov ID
- NCT03346850
- Acronym / sponsor ID
- HSC-MS-17-0725
- Conditions
- Enteral Feeding in Bronchiolitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of equipoise among enrolling clinicians, as well as emergence of external literature showing safety of nasogastric tube (NGT) feeds.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 25 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasogastric tube (NGT) feeding | Active comparator | Device: Nasogastric tube (NGT) feeding |
| nasoduodenal tube (NDT) feeding | Active comparator | Device: Nasoduodenal tube (NDT) feeding |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All admitted patients for bronchiolitis requiring high flow nasal cannula therapy at Children's Memorial Hermann
Key exclusion criteria (4 listed)
- 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.
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 (NGT) feedingA nasogastric tube goes from the nose to the stomach. | Device | nasogastric tube (NGT) feeding |
| Nasoduodenal tube (NDT) feedingA nasoduodenal tube goes from the nose to the duodenum. | Device | nasoduodenal tube (NDT) feeding |
Primary outcome
Length of Respiratory Supprt
Time frame: from the time of hospital admission to discharge (about 6 days)
7 secondary outcomes
Number of Participants With Emesis
Time frame: from the time of hospital admission to discharge (about 6 days)
Peak Respiratory Support in Liters Per Minute
Time frame: from the time of hospital admission to discharge (about 6 days)
Number of Chest X-rays Obtained Among All Participants
Time frame: from the time of hospital admission to discharge (about 6 days)
Number of Participants Who Revisited the Emergency Room (ER)
Time frame: 7 days after discharge from hospital
Number of Participants Who Revisited the Emergency Room (ER)
Time frame: 30 days after discharge from hospital
Number of Participants Who Were Readmitted to the Hospital
Time frame: 7 days after discharge from initial hospital visit
Number of Participants Who Were Readmitted to the Hospital
Time frame: 30 days after discharge from initial hospital visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31061025Parlar-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.
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.
Raymond Parlar-Chun, MD principal investigator
The University of Texas Health Science Center, Houston
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 (NGT) feeding and Nasoduodenal tube (NDT) feeding in people with Enteral Feeding in Bronchiolitis, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 25 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Respiratory Supprt (time frame: from the time of hospital admission to discharge (about 6 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03346850, which also lists 1 linked publication.
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 25 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.