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Not yet recruiting NCT06634329

Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube

Observational Premature Birth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oro or Nasogastric tube feeding.
Who it may be relevant to
Registry conditions: Premature Birth. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Oro or Nasogastric tube feeding
    Parental involvement in their premature baby's feeding

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • - Well-being and withdrawal signs by the Dsilna grid : comparison of manual methods versus electric syringe administration [Time frame: 6 monts]
  • - Well-being and withdrawal signs by the Dsilna grid : comparison during administration by parents or nurses [Time frame: 6 monts]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

France · 1 center
  • Service de Pédiatrie - Hôpitaux Universitaires de Strasbourg — Strasbourg

Identifiers

NCT: NCT06634329 · CE-2024-56

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗