Actively Recruiting

Phase Not Applicable
Age: 8Weeks - 20Weeks
All Genders
NCT04250454

Early Intervention in Infants With Cerebral Palsy

Led by University of Copenhagen · Updated on 2024-05-09

36

Participants Needed

1

Research Sites

445 weeks

Total Duration

On this page

Sponsors

U

University of Copenhagen

Lead Sponsor

E

Elsass Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Contractures are a frequent cause of reduced mobility in children with Cerebral palsy (CP) already at the age of 2-3 years. Reduced muscle use and muscle growth have been suggested as key factors in the development of contractures, suggesting that efficient early prevention will have to involve stimuli that can facilitate muscle growth already before the age of 1 year. The present study protocol was developed to assess the effectiveness of an early intervention program, CONTRACT, on muscle growth and mobility in children at very high risk of CP compared with best standard care.

CONDITIONS

Official Title

Early Intervention in Infants With Cerebral Palsy

Who Can Participate

Age: 8Weeks - 20Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants younger than 17 weeks corrected age with suspected brain lesion determined by medical assessment, MRI, ultrasound, or absence of fidgety movements
  • Brain lesion severity must have been discussed with parents and associated risk of cerebral palsy explained
Not Eligible

You will not qualify if you...

  • Severe genetic abnormalities
  • Severe heart problems
  • Metabolic diseases
  • Infants still hospitalized

AI-Screening

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Trial Site Locations

Total: 1 location

1

Elsass Foundation

Charlottenlund, København City, Denmark, 2920

Actively Recruiting

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Research Team

J

Jens Nielsen, Professor

CONTACT

M

Maria Willerslev-Olsen, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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