NCT04380051

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
82mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jan 2023Jan 2033

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 19, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2027

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2033

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

May 5, 2020

Last Update Submit

February 18, 2026

Conditions

Very Preterm Birth

Outcome Measures

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.

    12 months

Secondary Outcomes (1)

  • Social cognition / Theory of mind

    6 years

Study Arms (2)

Arm 1 : skin-to-skin contact associated with a sensory-tonic s

EXPERIMENTAL

skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time

Behavioral: sensory-tonic stimulationBehavioral: skin-to-skin contact

Arm 2 : skin-to-skin contact only

ACTIVE COMPARATOR

skin-to-skin contact left free for parents

Behavioral: skin-to-skin contact

Interventions

sensory-tonic stimulationBEHAVIORAL

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

Arm 1 : skin-to-skin contact associated with a sensory-tonic s
skin-to-skin contactBEHAVIORAL

skin-to-skin contact left free for parents

Arm 1 : skin-to-skin contact associated with a sensory-tonic sArm 2 : skin-to-skin contact only

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • very preterm child (born before 32 weeks of amenorrhoea)
  • parents agreeing to participate to the study

You may not qualify if:

  • child born before 25 weeks of amenorrhoea
  • child with a birth weight less than 600 grams
  • child with congenital malformation
  • child with hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

Related Publications (1)

  • Guittard C, Novo A, Eutrope J, Gower C, Barbe C, Bednarek N, Rolland AC, Caillies S, Loron G. Protocol for a prospective multicenter longitudinal randomized controlled trial (CALIN) of sensory-tonic stimulation to foster parent child interactions and social cognition in very premature infants. Front Pediatr. 2023 Jan 16;10:913396. doi: 10.3389/fped.2022.913396. eCollection 2022.

    PMID: 36727004DERIVED

Central Study Contacts

Gauthier Loron

CONTACT

0326787878gloron@chu-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: participants are assigned to one of two or more groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

January 19, 2023

Primary Completion (Estimated)

January 19, 2027

Study Completion (Estimated)

January 19, 2033

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

FR(1)