Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03346850
Other study ID # HSC-MS-17-0725
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date April 1, 2019

Study information

Verified date March 2020
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Nasogastric tube (NGT) feeding
A nasogastric tube goes from the nose to the stomach.
Nasoduodenal tube (NDT) feeding
A nasoduodenal tube goes from the nose to the duodenum.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of Respiratory Supprt from the time of hospital admission to discharge (about 6 days)
Secondary Number of Participants With Emesis from the time of hospital admission to discharge (about 6 days)
Secondary Peak Respiratory Support in Liters Per Minute from the time of hospital admission to discharge (about 6 days)
Secondary Number of Chest X-rays Obtained Among All Participants from the time of hospital admission to discharge (about 6 days)
Secondary Number of Participants Who Revisited the Emergency Room (ER) 7 days after discharge from hospital
Secondary Number of Participants Who Revisited the Emergency Room (ER) 30 days after discharge from hospital
Secondary Number of Participants Who Were Readmitted to the Hospital 7 days after discharge from initial hospital visit
Secondary Number of Participants Who Were Readmitted to the Hospital 30 days after discharge from initial hospital visit