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Clinical Trials in France / NCT07495709
Starting soon Observational

Reactions to Oro-facial Solicitations : a Predictor of Eating Difficulties for Premature Babies of 36 Weeks Gestation Adjusted Age

NCT07495709 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-04-01
Last updated
2026-03-27

Condition(s) studied

Premature

Investigational drug(s) / intervention(s)

Oro-facial stimulation

Oro-facial stimulation: massages and sensory stimulation aimed at stimulating the oral-facial reflexes of newborns (hand-to-mouth connection, cardinal points, milk smell, digging, crushing (finger or teat), sucking (crushing + suction))

Study summary

The goal of this observational study is to assess the link between reactions to orofacial stimuli observed at 29 weeks of amenorrhoea, and feeding difficulties at 36 weeks of amenorrhoea, in babies born prematurely between 26 and 27 + 6 weeks of gestation, admitted to the CHSF between 1 May 2025 and 31 March 2026. The main questions it aims to answer are : Can reactions to orofacial stimulation in babies born very prematurely be used as a tool for early detection of feeding difficulties before discharge from hospital? Is it possible to establish a predictive score for potential feeding difficulties as early as 29 weeks of gestation corrected, based on reactions to orofacial stimuli ? Participants will have their reactions to orofacial stimulations recorded in the 'Suivi oralité' grid completed by the nurses in the neonatal medicine and intensive care unit, which will then collect.

Eligibility

Sex
ALL
Min age
26 Weeks
Max age
28 Weeks
Healthy volunteers
No
Inclusion Criteria: * Premature babies born between 26 and 27 + 6 weeks of gestation * Admitted to the CHSF between 1 May 2025 and 31 March 2026 * Criteria grid completed upon admission * Parents or guardians informed of the study and not opposed to it. Exclusion Criteria: * ENT malformation * Neurological pathology * Dysplasia or oxygen therapy greater than or equal to 0.3L/min (these children are seen systematically) * Extreme prematurity (gestational age less than 26 weeks) * Genetic syndrome * Anoxic-ischaemic encephalopathy * Digestive malformation

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Sud Francilien Corbeil-Essonnes France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07495709 on ClinicalTrials.gov ↗ ← All trials in France