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

NCT06027645 | Recruiting

• 1 other identifier: Premalocom2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Prematurity; Extreme Prematurity; Infant Development; Brain Damage; Motor and Developmental Delay

Keywords

Prematurity; Crawling; Early intervention; Motor development; Locomotion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Amiel-Tison Neurological Assessment

  at 39-42 gestational age, 2, 9, 12 months corrected age

• Prechtl assessment

  at 39-42 gestational age and 2 months corrected age

• Age and Stage questionnaire (ASQ) 3

  2, 6, 9, 12, 18, 28 corrected age and 5 years

• 2D & 3D analysis of movement

  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.

  2, 6, 9, 12, 24 months corrected age

Study Arms (2)

Crawli Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

Control group infants benefit from usual care

Interventions

Crawling stimulation with a mini-skateboard (i.e. the crawliskate) BEHAVIORAL

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).

Crawli Group

Eligibility Criteria

• Age: 39 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marianne Barbu-Roth: lead
• Ecole Pratique des Hautes Etudes: collaborator
• Université Paris Cité: collaborator
• San Francisco State University: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (3)

Hôpital Paris Saint-Joseph

Paris, 75014, France

RECRUITING

Cnrs Umr 8002

Paris, Île-de-France Region, 75006, France

RECRUITING

Hôpital Robert Debré

Paris, Île-de-France Region, 75019, France

RECRUITING

MeSH Terms

Conditions

Premature Birth; Brain Injuries; Learning Disabilities

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Marianne Barbu-Roth, PhD

  Centre National de la Recherche Scientifique, France

  STUDY CHAIR

• Valérie Biran, MD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Barbu-Roth, PhD

CONTACT

00336 18 61 09 15; barburoth@gmail.com

Elodie Hinnekens, PT, PhD

CONTACT

00336 31 75 24 20; elodie.hinnekens@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: March 29, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From 2025 to 2030
• Access Criteria: IPD will be made available upon reasonable request to corresponding author

Locations

FR (3)