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

NCT ID: NCT05992181

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-06-20

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.

Conditions

Premature Birth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

control group

With the speech therapy already in place in the department.

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental group

With the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation.

Group Type: EXPERIMENTAL

NEORTHO

Intervention Type: OTHER

early orofacial stimulation

Interventions

NEORTHO

early orofacial stimulation

Intervention Type: OTHER

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.

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Countries

France

Other Identifiers

2023-A01290-45

Identifier Type: -

Identifier Source: org_study_id