Clinical Trials Directory

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

TypeNameDescription
DEVICEmethod of fixation of the orogastric tubeMethods 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.