Early Intervention Based on Neonatal Crawling in Very Premature Infants Without Major Brain Damage (Premalocom1)

Marianne Barbu-Roth

Status: Active, not recruiting

Conditions: Prematurity

Treatments: Behavioral: Crawling stimulation with the crawliskate; Behavioral: Tummy time without the crawliskate

Study type: Interventional

Funder types: Other

Identifiers

NCT05278286

ANR-20-CE17-0014 (Other Grant/Funding Number)

Premalocom1

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 37 to 42 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups

Crawli Group

Experimental group

Description:

Participants from the Crawli Group will benefit from the crawling stimulation intervention with the crawliskate

Treatment:

Behavioral: Crawling stimulation with the crawliskate

Mattress Group

Active Comparator group

Description:

Participants from the Mattress Group will benefit from the tummy time intervention

Treatment:

Behavioral: Tummy time without the crawliskate

Control Group

No Intervention group

Description:

Control group infants benefit from usual care.