Clinical trial NCT05278286: Early Intervention Based on Neonatal Crawling in Very Premature Infants Without Major Brain Damage
Official title: Effects of Early Crawling Training on the Motor Development of Very Premature Infants Without Major Brain Damage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prematurity
Lead sponsor: Centre National de la Recherche Scientifique, France
Sponsor class: OTHER
Collaborators: name: Ecole Pratique des Hautes Etudes
First posted: 2022-03-14
Enrollment: 48
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In our previous studies, we discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that we designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants.

The specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as median risk for developmental delay.

Methodology: We will study and follow three groups of very premature infants born between 24 and 32 weeks of gestational age without major brain lesions. These infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), one group of infants will be trained at home by physiotherapists positioned prone on a mattress (Mattress group) and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1) their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 24 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 24 months CA : BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years.

Expected results: Our first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive mattress training or no training.


Eligibility criteria: Inclusion Criteria:

* Term between 24-32 GA
* parental consent
* family living in intervention area
* good tolerance on the first crawliskate trial

Exclusion Criteria:

* no bronchodysplasia define by oxygen dependency after 36 GA
* no medical disease
* no limb deformity
* no karyotype anomaly
* no visual or auditory inpairment

Primary outcomes:
measure: Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.
timeFrame: 12 months corrected age
Secondary outcomes:
measure: Amiel-Tison Neurological Assessment
timeFrame: at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age
measure: Prechtl assessment
timeFrame: at 37-41 gestational age and 2 months corrected age
measure: Age and Stage questionnaire (ASQ) 3
timeFrame: 2, 6, 9, 12, 18, 24 corrected age and 5 years
measure: 2D & 3D analysis of movement
timeFrame: at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age
measure: All scores from the Bayley Scale of Infant and toddlers Development III ed.
timeFrame: 24 months corrected age
measure: Fine and gross motor scores from the Bayley Scale of Infant and toddlers Development III ed.
timeFrame: 2, 6, 9, 12, 18 months corrected age
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP
state: Ile De France
city: Paris
country: France
facility: Cnrs Umr 8002
state: Ile-de-France
Study officials:
affiliation: Centre National de la Recherche Scientifique, France
name: Marianne Barbu-Roth, PhD
role: STUDY_CHAIR
affiliation: APHP
name: Valérie Biran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: