RECRUITING

Natural History of Cerebral Palsy Prospective Study

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.

Official Title

Understanding the Early Natural History of Cerebral Palsy - A Prospective Cohort Study

Quick Facts

Study Start:2022-09-08

Study Completion:2026-09-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05576948

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Months to 24 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Infants will be included if they have a diagnosis of CP or "at high risk of CP" and under the age of 12 months. * Infants at high risk of CP as defined by any two (any combination) of the following: 1. Neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, Basal Ganglia, Posterior Limb of the Internal Capsule, pyramids. 2. Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age 3. Hammersmith Infant Neurological Exam (HINE) scores \<57 @ 3months or \<60 @ 6months or \<63 @9 months	* Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP * Infants with other disability diagnoses e.g. Down Syndrome

Inclusion Criteria

Exclusion Criteria

* Infants will be included if they have a diagnosis of CP or "at high risk of CP" and under the age of 12 months.
* Infants at high risk of CP as defined by any two (any combination) of the following:
1. Neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, Basal Ganglia, Posterior Limb of the Internal Capsule, pyramids.
2. Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age
3. Hammersmith Infant Neurological Exam (HINE) scores \<57 @ 3months or \<60 @ 6months or \<63 @9 months

* Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
* Infants with other disability diagnoses e.g. Down Syndrome

Contacts and Locations

Study Contact

Karen L Harpster, PhD

CONTACT

513-803-3604

karen.harpster@cchmc.org

Kelly Greve, PhD

CONTACT

(513) 636-3605

kelly.greve@cchmc.org

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-08

Study Completion Date2026-09-08

Study Record Updates

Study Start Date2022-09-08

Study Completion Date2026-09-08

Terms related to this study

Additional Relevant MeSH Terms

Cerebral Palsy