Study of Swaddling on Tactile Learning in Premature Infants

NCT04315428 | Completed

• 1 other identifier: 38RC18.060
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Premature Newborn

Outcome Measures

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 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 Outcomes (1)

• Compare cognitive development at 2 years in both groups

  between first evaluation and 2 years

Study Arms (2)

premature swaddled

the childs in this group will be wrap in a lange (swaddled)

Behavioral: swaddling

premature no swaddled

the childs in this group will be not swaddled

Behavioral: no swaddling

Interventions

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

premature swaddled

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

premature no swaddled

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Children born prematurely and aged 28 to 35 Weeks of Amenorrhoea, regardless of their postnatal age

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• GeneveUniversity: collaborator

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38000, France

Location

Related Publications (1)

• 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.

  PMID: 33291020 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Leïla MARCUS, Dr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: March 19, 2020
• Study Start: December 12, 2018
• Primary Completion: May 23, 2019
• Study Completion: May 23, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

FR (1)