Fixation of the Orogastric Tube: Which Method for the Newborn ?
BABAFIX
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
February 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedApril 5, 2021
April 1, 2021
2 years
January 15, 2020
April 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Average duration of holding the fixation
7 days
Secondary Outcomes (1)
Number of tube's dislodgements
7 days
Study Arms (2)
mustache fixation
ACTIVE COMPARATORW.K fixation
EXPERIMENTALInterventions
Methods of fixation of the orogastric tube will be randomized
Eligibility Criteria
You may qualify if:
- Newborns admitted to neonatal intensive care unit
- Express consent of the holders of parental authority
- Orogastric tube indication (enteral feeding, digestive aspiration)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire de la Réunion
Saint-Pierre, 97448, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 18, 2020
Study Start
February 12, 2020
Primary Completion
February 11, 2022
Study Completion
March 1, 2022
Last Updated
April 5, 2021
Record last verified: 2021-04