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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-4
SponsorElsan

About this trial

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.

Eligibility criteria

Qualifiers

For premature infants: birth between 30 and 34 weeks of gestation plus 6 days, and weighing more than 1800 g at the start of the trial.

For full-term infants: pregnancy and birth without complications at or after 37 weeks of gestation, with an Apgar score ≥7 at 10 minutes after birth.

Parents over the age of 18

Parent agreeing to be filmed with their infant (parent who will be responsible for the treatment)

Disqualifiers

Birth before 30 weeks of gestation

Weight less than 1800 g at the start of the trial

Morbidities related to prematurity (necrotizing enterocolitis, cerebral parenchymal damage, stage III and IV intraventricular hemorrhages)

Presence of a congenital malformation or chromosomal abnormality

Trial design

Treatments tested in this trial

  • ATVV (Auditory, Tactile, Visual and Vestibular stimulation)
  • Singing

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Elsan

Lead sponsor

Clinique Bouchard

Collaborator