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

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ClinicalTrials.gov Identifier: NCT05992181
Recruitment Status : Recruiting
First Posted : August 15, 2023
Last Update Posted : October 16, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Sud Francilien

Study Description
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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
Premature Birth Other: NEORTHO Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 Care for Premature Newborns
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : June 15, 2024
Estimated Study Completion Date : June 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   24 Hours to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05992181


Contacts
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Contact: Caroline BALANCON 01 61 69 37 31 caroline.balancon@chsf.fr
Contact: Caroline TOURTE 01 61 69 31 50 caroline.tourte@chsf.fr

Locations
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France
Centre Hospitalier Sud Francilien Recruiting
Corbeil-Essonnes, France, 91106
Contact: Caroline BALANCON    01 61 69 37 31    caroline.balancon@chsf.fr   
Contact: Véronique ZUPAN-SIMUNEK, MD       veronique.zupan@aphp.fr   
Principal Investigator: Caroline BALANCON         
Sub-Investigator: Solène BONNET         
Sub-Investigator: Sixtine CASAGRANDE         
Sponsors and Collaborators
Centre Hospitalier Sud Francilien
More Information
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Responsible Party: Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier: NCT05992181    
Other Study ID Numbers: 2023-A01290-45
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: October 16, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communication Disorders
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders