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Completed

NCT Number: NCT05992181

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

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

24 hour–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NEORTHO

Other

early orofacial stimulation

Primary outcomes

  1. Milk taken daily

    Time frame: up to 3 months

    Percentage of the amount of milk taken daily (measure taken once per week throughout the study).

Secondary outcomes

  1. Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)

    Time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90

    Analysis of oral and suction reflexes : global observation and functional assessment. (0=absent to 2=normal)

  2. Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaire

    Time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90

    feeding behavior scale for premature infants moving to bottle-feeding (0=absent to 18=normal)

  3. Milk flower (PIBBS questionnaire)

    Time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90

    global observation and functional assessment (0=absent to 20=normal)

  4. Newborn Pain and Discomfort Scale (EDIN questionnaire)

    Time frame: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90

    Newborn Pain and Discomfort Scale (0=normal to 15=painful)

  5. anxiety questionnaire

    Time frame: Day 0, Day 30, Day 60, Day 90

    anxiety questionnaire for the parents (0=relaxed to 2=anxious)

  6. satisfaction questionnaire

    Time frame: Day 90

    satisfaction questionnaire for the application (0=unsatisfied to 3=satisfied)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: NEORTHO

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2023
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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