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

NCT ID: NCT04380051

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2033-01-19

Brief Summary

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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

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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.

Conditions

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Very Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

sensory-tonic stimulation

Intervention Type 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

Intervention Type BEHAVIORAL

skin-to-skin contact left free for parents

Arm 2 : skin-to-skin contact only

skin-to-skin contact left free for parents

Group Type ACTIVE_COMPARATOR

skin-to-skin contact

Intervention Type BEHAVIORAL

skin-to-skin contact left free for parents

Interventions

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sensory-tonic stimulation

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

Intervention Type BEHAVIORAL

skin-to-skin contact

skin-to-skin contact left free for parents

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Reims

Reims, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gauthier Loron

Role: CONTACT

Phone: 0326787878

Email: [email protected]

Facility Contacts

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Damien JOLLY

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36727004 (View on PubMed)

Other Identifiers

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PR20064*

Identifier Type: -

Identifier Source: org_study_id