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

Study Overview
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Brief Summary
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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.

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

Conditions
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Enteral Feeding, Gastric Emptying

Intervention / Treatment
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* Device: method of fixation of the orogastric tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mustache fixation<br> | Device: method of fixation of the orogastric tube<br>* Methods of fixation of the orogastric tube will be randomized<br>|
| Experimental: W.K fixation<br> | Device: method of fixation of the orogastric tube<br>* Methods of fixation of the orogastric tube will be randomized<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average duration of holding the fixation |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of tube's dislodgements |  | 7 days |