Skip to main content
Clinical Trials/NCT06634329
NCT06634329
Not yet recruiting
Not Applicable

Assessment of the Comfort of Preterm Newborns During Feeding, Comparison of Different Methods of Milk Administration With Gastric Tube

University Hospital, Strasbourg, France1 site in 1 country50 target enrollmentNovember 2024
ConditionsPremature Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
University Hospital, Strasbourg, France
Enrollment
50
Locations
1
Primary Endpoint
Comparing the tolerance of these different types of food (gravity versus pushing the seringue), based on the child's behavioral and physiological signs of well-being.
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing.

In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous administration), or manual and individualization administration. In this second case, milk can be delivered by gravity, depending on the height the syringe is placed above the infant, or by manually pushing on the syringe. Milk can be administrated by nurses or by the parents after a learning period.

In this observational study, we would like to compare the preterm infants' behavioral during these different naso or oro gastric feeding modes by observing well-being signs and withdrawal signs (Dsilna grid) on video settings.

Registry
clinicaltrials.gov
Start Date
November 2024
End Date
November 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Hospitalized at the University Hospitals of Strasbourg during October 2024 and October 2025
  • Needing nasogastric tube feeding during at least 4 days
  • With parents (legal representants) having expressed their agreement with the use of video recording in the framework of the current study

Exclusion Criteria

  • ORL malformations
  • Neurological dysfunction
  • Sedated infant

Outcomes

Primary Outcomes

Comparing the tolerance of these different types of food (gravity versus pushing the seringue), based on the child's behavioral and physiological signs of well-being.

Time Frame: 6 months

Observation of preterm infants during and after naso/oro gastric tube feeding on videos to record well-being and withdrawal signs like classified in the Dsilna grid every 4 minutes.

Secondary Outcomes

  • - Well-being and withdrawal signs by the Dsilna grid : comparison of manual methods versus electric syringe administration(6 monts)
  • - Well-being and withdrawal signs by the Dsilna grid : comparison during administration by parents or nurses(6 monts)

Study Sites (1)

Loading locations...

Similar Trials