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

Very Preterm Birth Clinical Trial

— CALIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04380051
• Other study ID #: PR20064*
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: January 19, 2032

Study information

• Verified date: March 2024
• Source: CHU de Reims
• Contact: Gauthier Loron
• Phone: 0326787878
• Email: gloron[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 19, 2032
• Est. primary completion date: January 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Very Preterm Birth

Intervention

Behavioral:
• sensory-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
skin-to-skin contact left free for parents

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Social cognition / Theory of mind	small stories involving the thinking and feelings of character	6 years