Study of Swaddling on Tactile Learning in Premature Infants (EMMASENS)

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

Study Overview

• Status: Completed
• Conditions: Premature Newborn
• Intervention / Treatment: Behavioral: swaddling; Behavioral: no swaddling

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • Chu Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children born prematurely and hospitalized in the neonatal and neonatal resuscitation unit at the University Hospital of Grenoble

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
premature swaddled; the childs in this group will be wrap in a lange (swaddled)	Behavioral: 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
premature no swaddled; the childs in this group will be not swaddled	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare cognitive development at 2 years in both groups	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	between first evaluation and 2 years

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: GeneveUniversity
• Investigators: Principal Investigator: Leïla MARCUS, Dr, University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): May 23, 2019
• Study Completion (Actual): May 23, 2019

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 38RC18.060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No