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Search / Trial NCT06027645

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

Launched by MARIANNE BARBU-ROTH · Aug 31, 2023

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Prematurity Crawling Early Intervention Motor Development Locomotion

ClinConnect Summary

This clinical trial is studying a new way to help very premature infants, who are at risk for developmental delays, improve their motor skills and brain development. The researchers want to see if training these infants to crawl on a specially designed mini skateboard called the Crawliskate can help them develop better and faster than those who do not receive this training. The study will involve infants born extremely early (between 24 and 32 weeks of gestation) and will compare two groups: one group will practice crawling with their parents’ help for two months after leaving the hospital, while the other group will receive standard care without crawling training.

To be eligible for the study, infants must meet certain criteria, such as being born between 24-26 weeks or 26-32 weeks with specific brain issues, and their families must give consent. Participants can expect to be part of a supportive program where they will be guided by physiotherapists to practice crawling at home. The research aims to find out if this early crawling training helps these infants develop their motor skills and cognitive abilities better than their peers who do not receive the training. Overall, the study hopes to provide valuable insights into improving outcomes for very premature infants.

Gender

ALL

Eligibility criteria

  • 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

About Marianne Barbu Roth

Marianne Barbu-Roth is a dedicated clinical trial sponsor specializing in innovative research and development within the pharmaceutical and biotechnology sectors. With a strong commitment to advancing medical science, she leads initiatives aimed at evaluating new therapies and treatment modalities. Her expertise encompasses study design, regulatory compliance, and patient safety, ensuring that clinical trials are conducted with the highest ethical standards and scientific rigor. Through collaborative partnerships and a focus on patient-centered outcomes, Marianne Barbu-Roth strives to contribute to the advancement of healthcare and improve therapeutic options for diverse patient populations.

Locations

Paris, , France

Paris, Ile De France, France

Paris, Ile De France, France

Patients applied

0 patients applied

Trial Officials

Marianne Barbu-Roth, PhD

Study Chair

Centre National de la Recherche Scientifique, France

Valérie Biran, MD, PhD

Principal Investigator

APHP

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported