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

NCT05992181 | Completed

• 1 other identifier: 2023-A01290-45
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

• Milk taken daily

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

  up to 3 months

Secondary Outcomes (6)

• 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

• 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

• Milk flower (PIBBS questionnaire)

  Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90

• Newborn Pain and Discomfort Scale (EDIN questionnaire)

  Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90

• anxiety questionnaire

  Day 0, Day 30, Day 60, Day 90

Study Arms (2)

control group

NO INTERVENTION

With the speech therapy already in place in the department.

experimental group

EXPERIMENTAL

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

Other: NEORTHO

Interventions

NEORTHO OTHER

early orofacial stimulation

experimental group

Eligibility Criteria

• Age: 24 Hours - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 15, 2023
• Study Start: September 15, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)