Study of Swaddling on Tactile Learning in Premature Infants

Premature Newborn Clinical Trial

— EMMASENS  

Official title:

Study of Swaddling on Tactile Learning in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315428
• Other study ID #: 38RC18.060
• Status: Completed
• Start date: December 12, 2018
• Est. completion date: May 23, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 23, 2019
• Est. primary completion date: May 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Newborn

Intervention

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
• 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

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	GeneveUniversity

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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