Clinical trial NCT05992181: Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns
Official title: Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Milk taken daily
timeFrame: up to 3 months
Secondary outcomes:
measure: Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)
timeFrame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
measure: Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaire
timeFrame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
measure: Milk flower (PIBBS questionnaire)
timeFrame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
measure: Newborn Pain and Discomfort Scale (EDIN questionnaire)
timeFrame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
measure: anxiety questionnaire
timeFrame: Day 0, Day 30, Day 60, Day 90
measure: satisfaction questionnaire
timeFrame: Day 90
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References: