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

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Other: NEORTHO

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Corbeil-Essonnes, France, 91106
    • Centre hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Milk taken daily	Percentage of the amount of milk taken daily (measure taken once per week throughout the study).	up to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Neurodevelopmental Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Communication Disorders
• Other Study ID Numbers: 2023-A01290-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No