Study of Swaddling on Tactile Learning in Premature Infants

NCT ID: NCT04315428

Last Updated: 2020-03-19

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

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-12

Study Completion Date

2019-05-23

Brief Summary

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Explore the sensorially of the premature newborn that is fundamental to adapting the care environment to these hospitalized babies

Detailed Description

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Indeed, the challenge is to offer them an environment adapted to their sensory skills, so as not to alter their development.

This is in line with the customized care development, better known as the Anglo-Saxon term of Neonatal Individualised Developmental Care and Assessment Program.

The aim is thus to promote later the cognitive development of these children

Conditions

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Premature Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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premature swaddled

the childs in this group will be wrap in a lange (swaddled)

swaddling

Intervention Type BEHAVIORAL

The two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed

premature no swaddled

the childs in this group will be not swaddled

no swaddling

Intervention Type BEHAVIORAL

The two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed

Interventions

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swaddling

The two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed

Intervention Type BEHAVIORAL

no swaddling

The two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children born prematurely and aged 28 to 35 Weeks of Amenorrhoea, regardless of their postnatal age

Exclusion Criteria

premature newborns with

* associated anomalies syndrome
* abnormal cranial ultrasonography with stage III or IV intraventricular hemorrhage or periventricular cavitary leukaemia
* those receiving sedative or convulsive treatment during the experiment
* those whose grasping reflex is absent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GeneveUniversity

UNKNOWN

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leïla MARCUS, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Chu Grenoble Alpes

Grenoble, , France

Site Status

Countries

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France

References

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Lejeune F, Delacroix E, Gentaz E, Berne-Audeoud F, Marcus L, Debillon T. Influence of swaddling on tactile manual learning in preterm infants. Early Hum Dev. 2021 Feb;153:105288. doi: 10.1016/j.earlhumdev.2020.105288. Epub 2020 Dec 3.

Reference Type DERIVED
PMID: 33291020 (View on PubMed)

Other Identifiers

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38RC18.060

Identifier Type: -

Identifier Source: org_study_id

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