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

Study Overview
=================
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.

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

Conditions
-----------------
Very Preterm Birth

Intervention / Treatment
-----------------
* Behavioral: sensory-tonic stimulation
* Behavioral: skin-to-skin contact


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 1 Day

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 : skin-to-skin contact associated with a sensory-tonic s<br>skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time | Behavioral: sensory-tonic stimulation<br>* sensory-tonic stimulation done by the parents to the child, five times a week during 15 minutes at each time<br>Behavioral: skin-to-skin contact<br>* skin-to-skin contact left free for parents<br>|
| Active Comparator: Arm 2 : skin-to-skin contact only<br>skin-to-skin contact left free for parents | Behavioral: skin-to-skin contact<br>* skin-to-skin contact left free for parents<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interactions between parents and child | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social cognition / Theory of mind | small stories involving the thinking and feelings of character | 6 years |