Clinical Trial

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

Study acronym: PREMOTSENS
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07261046
Lead Sponsor Elsan
Collaborators: Clinique Bouchard
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
Enrollment 90 participants
Start Date 2025-12
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-12-03