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

NCT07495709 | Not Yet Recruiting

• 1 other identifier: 2025/0053
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature

Keywords

premature; Early intervention; orofacial stimulation; feeding difficulties; orality

Outcome Measures

Primary Outcomes (1)

• Enteral nutrition

  Necessity for newborns to be fed exclusively by enteral nutrition at 36 weeks' gestation for at least 24 hours, percentage of milk volume taken orally at 36 weeks' gestation compared to prescription, average duration of bottle feeding at 36 weeks' gestation

  at 36 weeks

Study Arms (1)

Preterm infants

Preterm infants born between 26 and 27+6 weeks of gestation

Other: Oro-facial stimulation

Interventions

Oro-facial stimulation OTHER

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))

Preterm infants

Eligibility Criteria

• Age: 26 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature babies hospitalised at the CHSF in neonatal resuscitation or intensive care units

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hasinirina RAZAFIMAHEFA, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasinirina Hasinirina RAZAFIMAHEFA, MD

CONTACT

+33; hasinirina.razafimahefa@chsf.fr

Caroline TOURTE

CONTACT

1 61 69 31 50; caroline.tourte@chsf.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)