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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorCHU de Reims

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

very preterm child (born before 32 weeks of amenorrhoea)

parents agreeing to participate to the study

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • sensory-tonic stimulation

    Behavioral

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

  • skin-to-skin contact

    Behavioral

    skin-to-skin contact left free for parents

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm 1 : skin-to-skin contact associated with a sensory-tonic sExperimental treatment 2 interventions
Group B: Arm 2 : skin-to-skin contact onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

Social cognition / Theory of mind

small stories involving the thinking and feelings of character

Time frame
6 years

Other outcomes

Sponsors and contacts

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