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Fixation of the Orogastric Tube: Which Method for the Newborn ?

NCT04233333 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-05

No results posted yet for this study

Summary

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.

Conditions

  • Enteral Feeding
  • Gastric Emptying

Interventions

DEVICE

method of fixation of the orogastric tube

Methods of fixation of the orogastric tube will be randomized

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de la Réunion

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2022-02-11
Completion
2022-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233333 on ClinicalTrials.gov