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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04233333
Acronym
BABAFIX
Enrollment
30
Registered
2020-01-18
Start date
2020-02-12
Completion date
2022-03-31
Last updated
2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding, Gastric Emptying

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.

Interventions

DEVICEmethod of fixation of the orogastric tube

Methods of fixation of the orogastric tube will be randomized

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Months
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

Design outcomes

Primary

MeasureTime frame
Average duration of holding the fixation7 days

Secondary

MeasureTime frame
Number of tube's dislodgements7 days

Countries

France

Contacts

Primary ContactLucie AUZANNEAU
lucie.auzanneau@chu-reunion.fr(0)262 35 99 49

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026