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

Sponsor
Centre Hospitalier Sud Francilien (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05992181
Collaborator
(none)
40
1
2
12
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: NEORTHO
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Development of a Digital Tool for the Individualization of Speech Therapy for Premature Newborns
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

With the speech therapy already in place in the department.

Experimental: experimental group

With the speech therapy already in place in the department, plus access to videos and the introduction of early orofacial stimulation.

Other: NEORTHO
early orofacial stimulation

Outcome Measures

Primary Outcome Measures

  1. Milk taken daily [up to 3 months]

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

Secondary Outcome Measures

  1. 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 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 [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) [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) [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 [Day 0, Day 30, Day 60, Day 90]

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

  6. satisfaction questionnaire [Day 90]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Hours to 3 Months
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Sud Francilien Corbeil-Essonnes France 91106

Sponsors and Collaborators

  • Centre Hospitalier Sud Francilien

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier:
NCT05992181
Other Study ID Numbers:
  • 2023-A01290-45
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2023