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Clinical Trials in France / NCT07261046
Starting soon Not applicable

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

NCT07261046 · tracked via the Priya Life Science France tracker
Sponsor
Elsan
Phase
Not applicable
Started
2025-12
Last updated
2025-12-03

Condition(s) studied

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

Investigational drug(s) / intervention(s)

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

ATVV (Auditory, Tactile, Visual and Vestibular stimulation): ATVV consists in providing the infant with multisensory stimulation through massage, talking, eye contact, and gentle rocking.

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

Study 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.

Eligibility

Sex
ALL
Min age
0 Weeks
Max age
4 Weeks
Healthy volunteers
Accepted
Inclusion Criteria: 1. 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. 2. 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. 3. For parents or legal guardians: * Parents over the age of 18 * Parent agreeing to be filmed with their infant (parent who will be responsible for the treatment) * Parents capable of understanding the information document * Parent affiliated with or beneficiary of the French social security system * Parents who have been informed and have freely given their informed written consent no later than the day of inclusion. Exclusion Criteria: 1. For premature infants: * 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 * Known sensory, motor, or central nervous system impairment * Patient receiving non-invasive ventilation at 34 weeks gestational age (CPAP and high-flow nasal cannula) 2. For full-term infants: * Birth before 37 weeks gestation * Birth with complications 3. For the parent providing the treatment and the infant: * Presence of a known sensory, motor, or central nervous system impairment * Presence of a congenital condition * Presence of psychological distress in the parent 4. For both parents: * Under guardianship, conservatorship, or legal protection * Situation of extreme psychosocial instability and/or mention of domestic and/or intra-family violence * Illicit drug or alcohol use by the mother during the perinatal period * Participant is in another study with an ongoing exclusion period during inclusion * Involuntary hospitalization

Primary outcome measure(s)

  • Analysis of the long-term impact of ATVV care on premature infants — The primary endpoint will be measured at 6 months corrected age in premature infants, and at 6 months in full-term infants.
    The primary objective is to analyze the long-term impact of ATVV care on premature infants. Motor and cognitive development at 6 months will be compared between premature infants (30 to 34 weeks gestation) receiving ATVV care with premature infants receiving "Singing" care and full-term infants (\>37 weeks gestation), using the Bayley Scales of Infant and Toddler Development, 4th Edition (from 16 days to 42 months) and its motor subscore (assessing fine and gross motor skills) and cognition subscore. A subscore (standardized score) ≥ 85 out of 160 in each domain corresponds to typical development.

Trial sites (2)

FacilityCityRegionStatus
Clinique Bouchard Marseille France
Hopital Saint-Joseph Marseille France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07261046 on ClinicalTrials.gov ↗ ← All trials in France