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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05992181
Acronym
NEORTHO
Enrollment
30
Registered
2023-08-15
Start date
2023-09-15
Completion date
2024-06-20
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

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.

Interventions

OTHERNEORTHO

early orofacial stimulation

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 3 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Milk taken dailyup to 3 monthsPercentage of the amount of milk taken daily (measure taken once per week throughout the study).

Secondary

MeasureTime frameDescription
Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaireDay 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90feeding behavior scale for premature infants moving to bottle-feeding (0=absent to 18=normal)
Milk flower (PIBBS questionnaire)Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90global observation and functional assessment (0=absent to 20=normal)
Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90Analysis of oral and suction reflexes : global observation and functional assessment. (0=absent to 2=normal)
anxiety questionnaireDay 0, Day 30, Day 60, Day 90anxiety questionnaire for the parents (0=relaxed to 2=anxious)
satisfaction questionnaireDay 90satisfaction questionnaire for the application (0=unsatisfied to 3=satisfied)
Newborn Pain and Discomfort Scale (EDIN questionnaire)Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90Newborn Pain and Discomfort Scale (0=normal to 15=painful)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026