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Not yet recruitingNCT07495709RESOF-36Updated Mar 27, 2026

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

An observational study in Premature, sponsored by Centre Hospitalier Sud Francilien. Not yet recruiting at 1 site in France. Open to participants aged 26 Weeks to 28 Weeks. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Centre Hospitalier Sud Francilien · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
26 Weeks to 28 Weeks
Sex
All
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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.

02

Conditions studied

  • Premature

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Keywords

  • premature
  • Early intervention
  • orofacial stimulation
  • feeding difficulties
  • orality
03

In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's planned enrollment of 80 is below the median of 120 across 806 observational studies indexed under Premature Birth.

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Lead sponsor

Centre Hospitalier Sud Francilien is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Weeks to 28 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Preterm infants

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

    Other: Oro-facial stimulation

Interventions

  • OtherOro-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))

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What researchers measure

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

    Time frame: at 36 weeks

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07495709
Lead sponsor
Centre Hospitalier Sud Francilien
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 27, 2026

Study contacts

Hasinirina Hasinirina RAZAFIMAHEFA, MD
Contact
hasinirina.razafimahefa@chsf.fr
+33 ext. 1 61 69 78 23
Caroline TOURTE
Contact
caroline.tourte@chsf.fr
1 61 69 31 50 ext. +33
Hasinirina RAZAFIMAHEFA, MD
principal investigator · Centre Hospitalier Sud Francilien

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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