Ireland
--:--IST
Recruiting Not applicable

Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children

NCT04380051 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-01-19
Last updated
2026-02-19

Condition(s) studied

Very Preterm Birth

Investigational drug(s) / intervention(s)

sensory-tonic stimulationskin-to-skin contact

sensory-tonic stimulation: sensory-tonic stimulation done by the parents to the child, five times a week during 15 minutes at each time

skin-to-skin contact: skin-to-skin contact left free for parents

Study summary

Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others.

Extreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment.

Early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.

Eligibility

Sex
ALL
Min age
—
Max age
1 Day
Healthy volunteers
No
inclusion criteria : * very preterm child (born before 32 weeks of amenorrhoea) * parents agreeing to participate to the study exclusion criteria : * child born before 25 weeks of amenorrhoea * child with a birth weight less than 600 grams * child with congenital malformation * child with hemodynamic instability

Primary outcome measure(s)

  • interactions between parents and child — 12 months
    Two free play sequences of 15 minutes will be filmed. The Coding Interactive Behavior (CIB; Feldman, 1998) contains 43 items (22 relating to parents, 16 relating to child and 5 related to parent-child dyad. Each item is rated from 1 (a little) to 5 (a lot). The Coding Interactive Behavior has 6 dimensions. The dimension "social commitment of the child" will be the primary outcome for this study.

Trial sites (1)

FacilityCityRegionStatus
Chu Reims Reims France Recruiting
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 NCT04380051 on ClinicalTrials.gov ↗ ← All trials in France