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

Not Applicable

Active, not recruiting

• Conditions: Prematurity
• Interventions: Behavioral: Crawling stimulation with the crawliskate; Behavioral: Tummy time without the crawliskate

• Registration Number: NCT05278286
• Lead Sponsor: Marianne Barbu-Roth

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-27
• Primary Completion: 2021-11-15
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crawli Group	Crawling stimulation with the crawliskate	Participants from the Crawli Group will benefit from the crawling stimulation intervention with the crawliskate
Mattress Group	Tummy time without the crawliskate	Participants from the Mattress Group will benefit from the tummy time intervention

Primary Outcome Measures

Name	Time	Method
Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.	12 months corrected age	The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain.; A score can be obtained for each aspect. At 12 months corrected age we only evaluate gross and fine motor scores, and we consider the gross motor score obtained at 12 months corrected age as the primary outcome of our study.; The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.

Secondary Outcome Measures

Name	Time	Method
Prechtl assessment	at 37-41 gestational age and 2 months corrected age	General movements assessment by video recording: measures the fluency and variability of spontaneous movement while the infant is lying supine on a mattress
Age and Stage questionnaire (ASQ) 3	2, 6, 9, 12, 18, 24 corrected age and 5 years	Parental appreciation of their infant development in personal-social, communication, gross motor, fine motor and problem solving domain The minimal score is 0 and the maximal score is 60. A higher score means more advanced skills.
All scores from the Bayley Scale of Infant and toddlers Development III ed.	24 months corrected age	The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain.; A score can be obtained for each aspect. At 24 months corrected age we evaluate the score from each aspect. The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.
Amiel-Tison Neurological Assessment	at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age	Infant neurological examination at study entry and after the training
2D & 3D analysis of movement	at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age	2D \& 3D analysis of movement (head control, sitting, crawling, stepping, walking) using qualysis and gaitrite system
Fine and gross motor scores from the Bayley Scale of Infant and toddlers Development III ed.	2, 6, 9, 12, 18 months corrected age	The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain.; A score can be obtained for each aspect. At 2, 6, 9, 12 and 18 months corrected age we only evaluate fine and gross motor scores. Note that the gross motor score obtained at 12 months corrected age is the primary outcome of our study but the fine motor score obtained at 12 months corrected age is also a secondary outcome.; The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.

Trial Locations

Locations (2)

Cnrs Umr 8002; 🇫🇷 Paris, Ile-de-France, France

APHP; 🇫🇷 Paris, Ile De France, France