Reactions to Oro-facial Solicitations : a Predictor of Ea... | NCT07495709

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

NCT07495709

Sponsor

Centre Hospitalier Sud Francilien

Status

Not yet recruiting

Last Update Posted

Mar 27, 2026Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Premature

Interventions

Oro-facial stimulation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 18, 2026

First Submission Date that Met QC Criteria

Mar 24, 2026

First Posted Date

Mar 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preterm infants		Preterm infants born between 26 and 27+6 weeks of gestation	Other: Oro-facial stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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))

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

26 Weeks

Maximum Age

28 Weeks

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hasinirina Hasinirina RAZAFIMAHEFA, MD	Contact	+33	1 61 69 78 23	hasinirina.razafimahefa@chsf.fr
Caroline TOURTE	Contact	1 61 69 31 50	+33	caroline.tourte@chsf.fr

Overall Officials

Name	Affiliation	Role
Hasinirina RAZAFIMAHEFA, MD	Centre Hospitalier Sud Francilien	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Sud Francilien		Corbeil-Essonnes	France	91100	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

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