Comparison of Two Early Treatments for Premature Babies and Their Effects Over Time

Summary

According to the latest World Health Organization report, prematurity is a major health issue, recognized as a significant vulnerability factor contributing to the emergence of neurodevelopmental disorders. Of the various approaches adopted to limit its consequences, the control of the sensory environment and sensory-focused care are relatively recent. Although a number of sensory care approaches exist, few of them address the different sensory modalities jointly and have been scientifically validated. This research project aims to conduct a study in France on the effectiveness of multisensory ATVV (Auditory, Tactile, Visual, and Vestibular stimulation) treatment using a combination of short- and long-term clinical assessments. The research hypothesis is that ATVV care provided before term age will have a greater impact than "Parental Singing" care on the motor parameters and alertness level of premature infants. Given the importance of motor activity on child development, it is hypothesized here that from term age onwards, the development of children in the ATVV group will be less atypical, or even equivalent to that of the group of full-term infants for most of the parameters evaluated. Furthermore, this normalization of the developmental trajectory will be less pronounced for the "Parental Singing" group. However, the sessions for both treatments (Parental Singing and ATVV) should improve early interactions, sucking, and physiological parameters.

Conditions

• Premature - Weight 1000g-2499g or Gestation of 28-37weeks
• Premature Baby 26 to 32 Weeks
• Premature Baby 33 to 36 Weeks
• Premature Between 32 and 36 Weeks of Amenorrhoea

Interventions

BEHAVIORAL

ATVV (Auditory, Tactile, Visual and Vestibular stimulation)

ATVV consists in providing the infant with multisensory stimulation through massage, talking, eye contact, and gentle rocking.

BEHAVIORAL

Singing

The singing intervention consists in parents singing softly next to the child's ear.

Sponsors & Collaborators

• Clinique Bouchard

  collaborator OTHER

• Elsan

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Weeks

Max Age

4 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-31

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• France

Study Locations