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

CHU de Reims

Status: Enrolling

Conditions: Very Preterm Birth

Treatments: Behavioral: skin-to-skin contact; Behavioral: sensory-tonic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04380051

PR20064*

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Arm 1 : skin-to-skin contact associated with a sensory-tonic s

Experimental group

Description:

skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time

Treatment:

Behavioral: sensory-tonic stimulation

Behavioral: skin-to-skin contact

Arm 2 : skin-to-skin contact only

Active Comparator group

Description:

skin-to-skin contact left free for parents

Treatment:

Behavioral: skin-to-skin contact