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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04380051
Acronym
CALIN
Enrollment
120
Registered
2020-05-08
Start date
2023-01-19
Completion date
2033-01-19
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Preterm Birth

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.

Interventions

BEHAVIORALsensory-tonic stimulation

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

skin-to-skin contact left free for parents

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

participants are assigned to one of two or more groups in parallel for the duration of the study

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Days
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

Design outcomes

Primary

MeasureTime frameDescription
interactions between parents and child12 monthsTwo 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

MeasureTime frameDescription
Social cognition / Theory of mind6 yearssmall stories involving the thinking and feelings of character

Countries

France

Contacts

CONTACTGauthier Loron
gloron@chu-reims.fr0326787878

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026