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Study of Swaddling on Tactile Learning in Premature Infants

Study of Swaddling on Tactile Learning in Premature Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04315428
Acronym
EMMASENS
Enrollment
40
Registered
2020-03-19
Start date
2018-12-12
Completion date
2019-05-23
Last updated
2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Newborn

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

Interventions

BEHAVIORALswaddling

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

BEHAVIORALno 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

Sponsors

GeneveUniversity
CollaboratorUNKNOWN
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 maxtime 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

MeasureTime frameDescription
Compare cognitive development at 2 years in both groupsbetween first evaluation and 2 yearsGlobal 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026