Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula

NCT ID: NCT03346850

Last Updated: 2020-03-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enteral Feeding in Bronchiolitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

nasogastric tube (NGT) feeding

Group Type ACTIVE_COMPARATOR

Nasogastric tube (NGT) feeding

Intervention Type DEVICE

A nasogastric tube goes from the nose to the stomach.

nasoduodenal tube (NDT) feeding

Group Type ACTIVE_COMPARATOR

Nasoduodenal tube (NDT) feeding

Intervention Type DEVICE

A nasoduodenal tube goes from the nose to the duodenum.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nasogastric tube (NGT) feeding

A nasogastric tube goes from the nose to the stomach.

Intervention Type DEVICE

Nasoduodenal tube (NDT) feeding

A nasoduodenal tube goes from the nose to the duodenum.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- All admitted patients for bronchiolitis requiring high flow nasal cannula therapy at Children's Memorial Hermann

Exclusion Criteria

* 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.
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Raymond Parlar-Chun

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raymond Parlar-Chun, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31061025 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-MS-17-0725

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Paediatric Microcuff Pressure Study
NCT03240354 COMPLETED NA
POM vs HFNC for Hypoxemia Prevention in Children
NCT07234188 NOT_YET_RECRUITING NA