Trials / Unknown
UnknownNCT04233333
Fixation of the Orogastric Tube: Which Method for the Newborn ?
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de la Réunion · Academic / Other
- Sex
- All
- Age
- 2 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | method of fixation of the orogastric tube | Methods of fixation of the orogastric tube will be randomized |
Timeline
- Start date
- 2020-02-12
- Primary completion
- 2022-02-11
- Completion
- 2022-03-01
- First posted
- 2020-01-18
- Last updated
- 2021-04-05
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04233333. Inclusion in this directory is not an endorsement.