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

Premature Birth Clinical Trial

— NEORTHO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992181
• Other study ID #: 2023-A01290-45
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: Caroline BALANCON
• Phone: 01 61 69 37 31
• Email: caroline.balancon[@]chsf.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Hours to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Communication Disorders
• Premature Birth

Intervention

Other:
• NEORTHO
early orofacial stimulation

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Milk taken daily	Percentage of the amount of milk taken daily (measure taken once per week throughout the study).	up to 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	anxiety questionnaire	anxiety questionnaire for the parents (0=relaxed to 2=anxious)	Day 0, Day 30, Day 60, Day 90
Secondary	satisfaction questionnaire	satisfaction questionnaire for the application (0=unsatisfied to 3=satisfied)	Day 90