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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Birth

Intervention / Treatment
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* Other: NEORTHO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>With the speech therapy already in place in the department. | |
| Experimental: experimental group<br>With the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation. | Other: NEORTHO<br>* early orofacial stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | feeding behavior scale for premature infants moving to bottle-feeding (0=absent to 18=normal) | Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | 
| Milk flower (PIBBS questionnaire) | global observation and functional assessment (0=absent to 20=normal) | Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | 
| Newborn Pain and Discomfort Scale (EDIN questionnaire) | Newborn Pain and Discomfort Scale (0=normal to 15=painful) | Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | 
| anxiety questionnaire | anxiety questionnaire for the parents (0=relaxed to 2=anxious) | Day 0, Day 30, Day 60, Day 90 | 
| satisfaction questionnaire | satisfaction questionnaire for the application (0=unsatisfied to 3=satisfied) | Day 90 |