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

Centre Hospitalier Universitaire de la Réunion

Status: Unknown

Conditions: Gastric Emptying; Enteral Feeding

Treatments: Device: method of fixation of the orogastric tube

Study type: Interventional

Funder types: Other

Identifiers

NCT04233333

2017/CHU/08

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

mustache fixation

Active Comparator group

Treatment:

Device: method of fixation of the orogastric tube

W.K fixation

Experimental group

Treatment:

Device: method of fixation of the orogastric tube