Fixation of the Orogastric Tube: Which Method for the Newborn ? (BABAFIX)

April 2, 2021 updated by: Centre Hospitalier Universitaire de la Réunion

It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn's cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. The "mustache" is usually used to fix it, but this interferes with the perioral zone and must be changed more often than necessary.

To achieve a more sustainable orogastric tube's fixation to the cheek, a German team directed by W. Krämer developed and tested an orogastric tube's fixing technique that was subsequently approved and used.

Using this German method, a randomized, monocentric superiority study, including 30 newborns and premature babies requiring an orogastric tube, will compared german probe's fixation method to the mustache.

The aim of the study is to ensure a more effective orogastric tube's fixation to reduce the number of fixation changes, probe placements and negative oral stimulations in newborns.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Saint-Pierre, France, 97448
        • Recruiting
        • Centre Hospitalier Universitaire de la Réunion
        • Principal Investigator:
          • Sylvie PAYET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newborns admitted to neonatal intensive care unit
  • Express consent of the holders of parental authority
  • Orogastric tube indication (enteral feeding, digestive aspiration)

Exclusion Criteria:

  • Newborns over 2 months of age corrected
  • Indication of nasogastric tube
  • Port of gastrostomy
  • Pathology resulting in hypersalivation or hyper sweating
  • Swallowing disorder
  • Genetic disease
  • Severe neurological impairment
  • Cleft lip and / or palate
  • Other malformation in the oral sphere or perioral area
  • Sedation with morphine analgesics
  • Anticonvulsant treatment
  • Palliative care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mustache fixation
Device: method of fixation of the orogastric tube
Methods of fixation of the orogastric tube will be randomized
Experimental: W.K fixation
Device: method of fixation of the orogastric tube
Methods of fixation of the orogastric tube will be randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average duration of holding the fixation
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of tube's dislodgements
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2020

Primary Completion (Anticipated)

February 11, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2017/CHU/08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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