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Status unknownNCT04233333BABAFIXUpdated Apr 5, 2021

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

An interventional study of method of fixation of the orogastric tube in Enteral Feeding and Gastric Emptying, sponsored by Centre Hospitalier Universitaire de la Réunion. Status unknown at 1 site in France. Open to participants aged Up to 2 Months. Per ClinicalTrials.gov, last updated 2021-04-05.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
Up to 2 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Enteral Feeding
  • Gastric Emptying
03

In context

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 137 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 2 Months
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    mustache fixation

    Device: method of fixation of the orogastric tube

  • Experimental
    W.K fixation

    Device: method of fixation of the orogastric tube

Interventions

  • Devicemethod of fixation of the orogastric tube

    Methods of fixation of the orogastric tube will be randomized

06

What researchers measure

Primary outcomes

  1. Average duration of holding the fixation

    Time frame: 7 days

Secondary outcomes

  1. Number of tube's dislodgements

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Universitaire de la Réunion
    Saint-Pierre, 97448, France
    • Lucie AUZANNEAU · Contact
    • Sylvie PAYET · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04233333
Lead sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible party
Sponsor
First posted
Jan 18, 2020
Start date
Feb 12, 2020
Primary completion
Feb 11, 2022 (estimated)
Completion
Mar 2022 (estimated)
Last update
Apr 5, 2021

Study contacts

Lucie AUZANNEAU
Contact
lucie.auzanneau@chu-reunion.fr
(0)262 35 99 49 ext. +262

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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