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

C

Centre Hospitalier Sud Francilien

Status

Completed

Conditions

Premature Birth

Treatments

Other: NEORTHO

Study type

Interventional

Funder types

Other

Identifiers

NCT05992181
2023-A01290-45

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

24 hours to 3 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Caroline TOURTE; Caroline BALANCON

Data sourced from clinicaltrials.gov

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