Fixation of the Orogastric Tube: Which Method for the Newborn ?
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Average duration of holding the fixation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 2 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
mustache fixation
Intervention: method of fixation of the orogastric tube (Device)
W.K fixation
Intervention: method of fixation of the orogastric tube (Device)
Outcomes
Primary Outcomes
Average duration of holding the fixation
Time Frame: 7 days
Secondary Outcomes
- Number of tube's dislodgements(7 days)