Study of Swaddling on Tactile Learning in Premature Infants

Completed

• Conditions: Premature Newborn
• Interventions: Behavioral: swaddling; Behavioral: no swaddling

• Registration Number: NCT04315428
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2018-12-12
• Primary Completion: 2019-05-23
• Study Completion: 2019-05-23
• Study First Submitted: 2019-12-19
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-17
• Last Update Submitted: 2020-03-17
• Study First Posted: 2020-03-19
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
premature swaddled	swaddling	the childs in this group will be wrap in a lange (swaddled)
premature no swaddled	no swaddling	the childs in this group will be not swaddled

Primary Outcome Measures

Name	Time	Method
time required to habituate a first object (corresponding to a time when the object is held repeatedly) and time required to present a new object (corresponding to the property of discrimination)	up to 3 months max	time required to habituate a first object (corresponding to a time when the object is held repeatedly) and time required to present a new object (corresponding to the property of discrimination)

Secondary Outcome Measures

Name	Time	Method
Compare cognitive development at 2 years in both groups	between first evaluation and 2 years	Global development quotient, derived from the Brunet-Lezine scale, (performed systematically as part of the normal follow-up of premature babies in the N\&D care network).; the Brunet-Lezine scale : it is a global development quotient (QD) which is calculated and which corresponds to a standardized score (average of 100). Higher score corresponds to better child development

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 Grenoble, France