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

NCT ID: NCT05278286

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2024-11-30

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.

Conditions

Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Crawli Group

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

Group Type: EXPERIMENTAL

Crawling stimulation with the crawliskate

Intervention Type: BEHAVIORAL

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.

Mattress Group

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

Group Type: ACTIVE_COMPARATOR

Tummy time without the crawliskate

Intervention Type: BEHAVIORAL

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.

Control Group

Control group infants benefit from usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 37 Weeks
• Maximum Eligible Age: 42 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecole Pratique des Hautes Etudes

OTHER

Sponsor Role: collaborator

Marianne Barbu-Roth

OTHER

Sponsor Role: lead

Responsible Party

Marianne Barbu-Roth

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marianne Barbu-Roth, PhD

Role: STUDY_CHAIR

Centre National de la Recherche Scientifique, France

Valérie Biran, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Cnrs Umr 8002

Paris, Île-de-France Region, France

APHP

Paris, Île-de-France Region, France

Countries

France

References

Dumuids-Vernet MV, Forma V, Provasi J, Anderson DI, Hinnekens E, Soyez E, Strassel M, Gueret L, Hym C, Huet V, Granjon L, Calamy L, Dassieu G, Boujenah L, Dollat C, Biran V, Barbu-Roth M. Stimulating the motor development of very premature infants: effects of early crawling training on a mini-skateboard. Front Pediatr. 2023 Jun 6;11:1198016. doi: 10.3389/fped.2023.1198016. eCollection 2023.

Reference Type: DERIVED

PMID: 37346892 (View on PubMed)

Other Identifiers

ANR-20-CE17-0014

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Premalocom1

Identifier Type: -

Identifier Source: org_study_id