Development of a Digital Tool for the Individualization o... | NCT05992181

Studies
Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns

NCT05992181

Sponsor

Centre Hospitalier Sud Francilien

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Premature Birth

Interventions

NEORTHO

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2023Actual

Primary Completion Date

Jun 20, 2024Actual

Completion Date

Jun 20, 2024Actual

First Submitted Date

Jul 28, 2023

First Submission Date that Met QC Criteria

Aug 11, 2023

First Posted Date

Aug 15, 2023Actual

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

Aug 14, 2024

Last Update Posted Date

Aug 15, 2024Actual

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 study concerns the creation and implementation of a digital tool presenting the various orofacial stimuli that can be offered to premature newborns. This app is intended for parents, to allow them to play a more active role in their child's care, and provide them with special time with their child. The notion of pleasure is very important to us, and it's vital to help parents rediscover this feeling with their child. Different profiles will be created to individualize our recommendations, facilitate the understanding of orofacial stimuli, make them more concrete than drawings, and provide care adapted to each patient and improve the development of newborns through more regular orofacial stimulation.

Detailed Description

Two groups will be formed:

Group A - control: receiving the speech therapy currently in place in the department.

Group B - experimental: will receive the same care as the first group, plus access to the videos and the introduction of early orofacial stimulation.

Group B: First, an initial assessment will be performed in speech-language pathology of the oro-myofunctional and oral functions of the newborn. This will determine which orofacial solicitations to give to the baby and create in the patient's profile.

Parents will be trained in orofacial stimulation and will be coached during the first sessions. When parents are ready, access will be given to their personal space on the application. Appointments will be scheduled to remodel the treatment if necessary. Sucking (ECEPAB), feeding (PIBBS) and behavioural (EDIN) abilities will be assessed. Parents will be asked to fill out a questionnaire about their feelings.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	No Intervention	With the speech therapy already in place in the department.
experimental group	Experimental	With the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation.	Other: NEORTHO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NEORTHO	Other	early orofacial stimulation	experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Milk taken daily	Percentage of the amount of milk taken daily (measure taken once per week throughout the study).	up to 3 months

Secondary Outcomes

Measure	Description	Time Frame
Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)	Analysis of oral and suction reflexes : global observation and functional assessment. (0=absent to 2=normal)	Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Child born prematurely before 29 weeks of amenorrhea (SA).
Alive for minimum 24h.
Holders of parental authority who have been informed of the study and have not objected.

Exclusion Criteria:

Child born after 29 weeks of amenorrhea.
with a genetic or severe neurological pathology or withdrawal syndrome.
with a vital prognosis.
whose family home is too far from the service.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Hours

Maximum Age

3 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Sud Francilien		Corbeil-Essonnes		91106	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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