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Completed

NCT Number: NCT04315428

Study of Swaddling on Tactile Learning in Premature Infants

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

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Key information

Conditions

Premature Newborn Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Grenoble Alpes

Grenoble, 38000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swaddling

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

no swaddling

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

Primary outcomes

  1. 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 frame: 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 outcomes

  1. Compare cognitive development at 2 years in both groups

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • GeneveUniversity

Registry information

Acronym: EMMASENS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2020
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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