Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interaction and Social Cognition in Very Premature Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- CHU de Reims
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- interactions between parents and child
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 1 Day (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Arm 1 : skin-to-skin contact associated with a sensory-tonic s
skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time
Intervention: sensory-tonic stimulation (Behavioral)
Arm 1 : skin-to-skin contact associated with a sensory-tonic s
skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time
Intervention: skin-to-skin contact (Behavioral)
Arm 2 : skin-to-skin contact only
skin-to-skin contact left free for parents
Intervention: skin-to-skin contact (Behavioral)
Outcomes
Primary Outcomes
interactions between parents and child
Time Frame: 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 Outcomes
- Social cognition / Theory of mind(6 years)