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

Not Applicable

Recruiting

• Conditions: Very Preterm Birth
• Interventions: Behavioral: skin-to-skin contact; Behavioral: sensory-tonic stimulation

• Registration Number: NCT04380051
• Lead Sponsor: CHU de Reims

Brief 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.

Detailed Description

The aim of the study is to evaluate impact of a sensory-tonic stimulation on development of parent-infant interaction and on social cognition in very premature children.

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Study Start: 2023-01-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2027-01-19
• Study Completion: 2033-01-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 : skin-to-skin contact only	skin-to-skin contact	skin-to-skin contact left free for parents
Arm 1 : skin-to-skin contact associated with a sensory-tonic s	sensory-tonic stimulation	skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time
Arm 1 : skin-to-skin contact associated with a sensory-tonic s	skin-to-skin contact	skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Social cognition / Theory of mind	6 years	small stories involving the thinking and feelings of character

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France