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

Gastric Emptying Clinical Trial

— BABAFIX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233333
• Other study ID #: 2017/CHU/08
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: March 2022

Study information

• Verified date: April 2021
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Lucie AUZANNEAU
• Phone: (0)262 35 99 49
• Email: lucie.auzanneau[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Enteral Feeding
• Gastric Emptying

Intervention

Device:
• method of fixation of the orogastric tube
Methods of fixation of the orogastric tube will be randomized

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average duration of holding the fixation		7 days
Secondary	Number of tube's dislodgements		7 days