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

Effects of Early Crawling Training on the Motor Development of Very Premature Infants Without Major Brain Damage

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prematurity
• Intervention / Treatment: Behavioral: Crawling stimulation with the crawliskate; Behavioral: Tummy time without the crawliskate

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75019
      • APHP
  • Ile-de-France
    • Paris, Ile-de-France, France, 75006
      • Cnrs Umr 8002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crawli Group; Participants from the Crawli Group will benefit from the crawling stimulation intervention with the crawliskate	Behavioral: Crawling stimulation with the crawliskate; Consists of 2 months of daily training. Infants benefit from a 5 minutes session everyday at home with a trained therapist. During each session the infant is prone wrapped on the crawliskate and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the therapist.
Active Comparator: Mattress Group; Participants from the Mattress Group will benefit from the tummy time intervention	Behavioral: Tummy time without the crawliskate; Consists of 2 months of daily training. Infants benefit from a 5-minutes session everyday at home with a trained therapist. During each session the infant is prone directly ona mattress and cannot benefit from any assistance from the therapist to move forward.
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 37-41 gestational age, 2, 6, 9, 12, 24 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 37-41 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, 24 corrected age and 5 years
2D & 3D analysis of movement	2D & 3D analysis of movement (head control, sitting, crawling, stepping, walking) using qualysis and gaitrite system	at 37-41 gestational age, 2, 6, 9, 12, 24 months corrected age
All 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 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.	24 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 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.	2, 6, 9, 12, 18 months corrected age

Collaborators and Investigators

• Sponsor: Marianne Barbu-Roth
• Collaborators: Ecole Pratique des Hautes Etudes
• 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 27, 2017
• Primary Completion (Actual): November 15, 2021
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: Premalocom1; ANR-20-CE17-0014 (Other Grant/Funding Number: Agence Nationale de la Recherche)

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 2035
• IPD Sharing Access Criteria: IPD will be made available upon reasonable request to corresponding author
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

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