Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder (Premalocom2)

Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder

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 previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that the investigators 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 high risk for developmental delay.

Methodology: The investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with 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 their parents under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli 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 and 6 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 12 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 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: The 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 no training.

Study Overview

• Status: Recruiting
• Conditions: Prematurity; Brain Damage; Infant Development; Extreme Prematurity; Motor and Developmental Delay
• Intervention / Treatment: Behavioral: Crawling stimulation with a mini-skateboard (i.e. the crawliskate)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne Barbu-Roth, PhD; Phone Number: 00336 18 61 09 15; Email: barburoth@gmail.com
• Study Contact Backup: Name: Elodie Hinnekens, PT, PhD; Phone Number: 00336 31 75 24 20; Email: elodie.hinnekens@gmail.com

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Hopital Paris Saint-Joseph
    • Contact: Laurence Boujenah, MD; Email: lboujenah@ghpsj.fr
  • Ile De France
    • Paris, Ile De France, France, 75006
      • Recruiting
      • Cnrs Umr 8002
      • Contact: Marianne Barbu-Roth, PhD; Phone Number: 0033618610915; Email: barburoth@gmail.com
      • Contact: Elodie Hinnekens, PT, PhD; Phone Number: 0033631752420; Email: elodie.hinnekens@gmail.com
    • Paris, Ile De France, France, 75019
      • Recruiting
      • Hôpital Robert Debré
      • Contact: Valérie Biran, MD, PhD; Phone Number: 00336 88 48 48 85; Email: valerie.biran@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Term between 24-26 GA or 26-32 GA with suspected brain lesion
• parental consent
• family living in intervention area
• good tolerance on the first crawliskate trial

Exclusion Criteria:

• no bronchodysplasia defined by oxygen dependency after 36 GA
• no medical disease
• no limb deformity
• no karyotype anomaly
• no visual or auditory impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crawli Group; Participants from the Crawli Group will benefit from the crawling stimulation intervention with a mini-skateboard (i.e. the crawliskate) in addition to usual care	Behavioral: Crawling stimulation with a mini-skateboard (i.e. the crawliskate); Consists of 8 weeks of daily training. Infants benefit from a 10 minutes session everyday at home with either a trained therapist or his/her parents. Parents are trained by the therapist at the begining of the 8 weeks. During each session the infant is prone wrapped on a mini-skateboard (i.e. the crawliskate) and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the adult (therapist or parent).
No Intervention: Control Group; Control group infants benefit from usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.	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.	12 months corrected age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amiel-Tison Neurological Assessment	Infant neurological examination at study entry and after the training	at 39-42 gestational age, 2, 9, 12 months corrected age
Prechtl assessment	General movements assessment by video recording: measures the fluency and variability of spontaneous movement while the infant is lying supine on a mattress	at 39-42 gestational age and 2 months corrected age
Age and Stage questionnaire (ASQ) 3	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.	2, 6, 9, 12, 18, 28 corrected age and 5 years
2D & 3D analysis of movement	2D & 3D analysis of movement (head control, sitting, crawling, stepping, walking) using a motion capture system.	at 39-42 gestational age, 2, 6, 9, 12 months corrected age
Fine and gross motor scores from the Bayley Scale of Infant and toddlers development III ed.	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 24 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.	2, 6, 9, 12, 24 months corrected age

Collaborators and Investigators

• Sponsor: Marianne Barbu-Roth
• Collaborators: Assistance Publique - Hôpitaux de Paris; San Francisco State University; Ecole Pratique des Hautes Etudes; Université Paris Cité
• Investigators: Study Chair: Marianne Barbu-Roth, PhD, Centre National de la Recherche Scientifique, France; Principal Investigator: Valérie Biran, MD, PhD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Early intervention; Prematurity; Motor development; Locomotion; Crawling
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Injuries; Premature Birth; Neurodevelopmental Disorders
• Other Study ID Numbers: Premalocom2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be made available upon reasonable request to corresponding author
• IPD Sharing Time Frame: From 2025 to 2030
• IPD Sharing Access Criteria: IPD will be made available upon reasonable request to corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No