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NCT Number: NCT04380051

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

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.

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Key information

Conditions

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Reims

Reims, 51092, France

Location status: Recruiting

Location contact

Damien JOLLY

CONTACT

[email protected]

326788472 ext. 33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Social cognition / Theory of mind

    Time frame: 6 years

    small stories involving the thinking and feelings of character

Study contacts

Contact information is provided by the study sponsor or research team.

Gauthier Loron

CONTACT

[email protected]

0326787878

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: CALIN

Important dates

Study start
2023
Primary completion
2027
Study completion
2033
First posted
May 8, 2020
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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