Back to resultsEvaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children (CALIN)
Primary Purpose
Very Preterm Birth
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sensory-tonic stimulation
skin-to-skin contact
Sponsored by
About this trial
This is an interventional treatment trial for Very Preterm Birth
Eligibility 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
Sites / Locations
- Chu ReimsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1 : skin-to-skin contact associated with a sensory-tonic s
Arm 2 : skin-to-skin contact only
Arm 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
skin-to-skin contact left free for parents
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Social cognition / Theory of mind
small stories involving the thinking and feelings of character
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04380051
Brief Title
Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children
Acronym
CALIN
Official Title
Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interaction and Social Cognition in Very Premature Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
January 19, 2025 (Anticipated)
Study Completion Date
January 19, 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Preterm Birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 : skin-to-skin contact associated with a sensory-tonic s
Arm Type
Experimental
Arm 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
Arm Title
Arm 2 : skin-to-skin contact only
Arm Type
Active Comparator
Arm Description
skin-to-skin contact left free for parents
Intervention Type
Behavioral
Intervention Name(s)
sensory-tonic stimulation
Intervention Description
sensory-tonic stimulation done by the parents to the child, five times a week during 15 minutes at each time
Intervention Type
Behavioral
Intervention Name(s)
skin-to-skin contact
Intervention Description
skin-to-skin contact left free for parents
Primary Outcome Measure Information:
Title
interactions between parents and child
Description
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 Outcome Measure Information:
Title
Social cognition / Theory of mind
Description
small stories involving the thinking and feelings of character
Time Frame
6 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gauthier Loron
Phone
0326787878
Email
gloron@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children
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