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

NCT ID: NCT04233333

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2022-03-31

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.

Conditions

Enteral Feeding; Gastric Emptying

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

mustache fixation

Group Type: ACTIVE_COMPARATOR

method of fixation of the orogastric tube

Intervention Type: DEVICE

Methods of fixation of the orogastric tube will be randomized

W.K fixation

Group Type: EXPERIMENTAL

method of fixation of the orogastric tube

Intervention Type: DEVICE

Methods of fixation of the orogastric tube will be randomized

Interventions

method of fixation of the orogastric tube

Methods of fixation of the orogastric tube will be randomized

Intervention Type: DEVICE

Eligibility Criteria

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

• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire de la Réunion

Saint-Pierre, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lucie AUZANNEAU

Role: CONTACT

lucie.auzanneau@chu-reunion.fr

(0)262 35 99 49 ext. +262

Facility Contacts

Lucie AUZANNEAU

Role: primary

Other Identifiers

2017/CHU/08

Identifier Type: -

Identifier Source: org_study_id