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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

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

  • Singing

    Behavioral

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: ATVV groupExperimental treatment 1 intervention
Group B: Parental Singing groupOther 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Analysis of the long-term impact of ATVV care on premature 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.

Time frame
The primary endpoint will be measured at 6 months corrected age in premature infants, and at 6 months in full-term infants.

Secondary outcomes

1

Motor skills

Three different motor skills will be measured: spontaneous motor skills, involving general movements and accelerometry (head/forearm/calf); voluntary motor skills, involving Crawliskate in the laboratory with a motion capture system; and oral motor skills, involving sucking a pacifier with a pressure sensor adapted for premature infants.

Time frame
The outcome is measured between 34 weeks gestational age and 2 months of corrected age.
2

Overall and communication development

The outcome is measured using the subscore for the receptive and expressive communication scales, and the ensemble of communication, motor, and cognitive subscores, from the Bayley Scales of Infant and Toddler Development, 4th Edition. A standardized score ≥ 85 out of 160 corresponds to typical development.

Time frame
The outcome is measured between 34 weeks gestational age and 2 months of corrected age.
3

Multisensory integration

A visuo-vestibular conflict paradigm using a device that measures head acceleration of the infant.

Time frame
The outcome is measured between 34 weeks gestational age and 2 months of corrected age.
4

Level of alertness

Alertness is evaluated on the Prechtl assessment scale, comprising 5 levels: quiet sleep; active/restless sleep; quiet wakefulness; restless wakefulness; and agitation.

Time frame
The outcome is measured between 34 weeks gestational age and 2 months of corrected age.

Other outcomes

Sponsors and contacts

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Elsan

Lead sponsor

Clinique Bouchard

Collaborator

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