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Not yet recruiting NCT07495709

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

Observational Premature

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-facial stimulation.
Who it may be relevant to
Registry conditions: Premature. Basic parameters: 26 Weeks — 28 Weeks · 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 →

Overview

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.

Interventions

  • Other 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))

Primary outcome measures

  • Enteral nutrition [Time frame: at 36 weeks]

Eligibility criteria

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

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
Cohort

Study locations

France · 1 center
  • Centre Hospitalier Sud Francilien — Corbeil-Essonnes

Identifiers

NCT: NCT07495709 · 2025/0053

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗