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

Not Applicable

• Conditions: Enteral Feeding; Gastric Emptying
• Interventions: Device: method of fixation of the orogastric tube

• Registration Number: NCT04233333
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-02-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-05
• Primary Completion: 2022-02-11
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mustache fixation	method of fixation of the orogastric tube	-
W.K fixation	method of fixation of the orogastric tube	-

Primary Outcome Measures

Name	Time	Method
Average duration of holding the fixation	7 days

Secondary Outcome Measures

Name	Time	Method
Number of tube's dislodgements	7 days

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de la Réunion; 🇫🇷 Saint-Pierre, France