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Clinical Trials/NCT04287166
NCT04287166
Active, not recruiting
Not Applicable

Feasibility of Remote Early At-risk Diagnosis for Cerebral Palsy in High-risk Infant Follow-up Clinics in The Central Norway Regional Health Authority

St. Olavs Hospital3 sites in 1 country100 target enrollmentAugust 3, 2020
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
St. Olavs Hospital
Enrollment
100
Locations
3
Primary Endpoint
Predictability of GMA and computer-based assessment for development of CP
Status
Active, not recruiting
Last Updated
10 months ago

Overview

Brief Summary

Cerebral Palsy (CP) is the most common motor dysfunction in childhood. Traditionally, diagnosis is set between 12 and 24 months of age. This study will evaluate feasibility of a new screening procedure for early detection of CP in high-risk infants and investigate how such a procedure can be implemented in the Central Norwegian Regional Health Authority (CNRHA).

The most accurate method to detect and predict CP at an early age is the General Movement Assessment (GMA). GMA is based upon expert observations of infant spontaneous movements in a video. In Central-Norway such expertise is today only present at St. Olavs Hospital, Trondheim University Hospital. Video recordings by health personnel and parents will be used in follow-up programs within CNRHA for remote expert based GMA. In addition, machine learning models will be applied for automatic detection of CP.

Early identification of CP will lead to improved function and increased possibility to direct health care resources to the patients who need it most, independent of geographical and expert based constraints.

Registry
clinicaltrials.gov
Start Date
August 3, 2020
End Date
December 2025
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • hospitalized at a Neonatal Intensive Care Unit (NICU) within the Central Norway Regional Health Authority that is referred to follow-up in the Specialist Health Services containing a team of minimum a pediatrician and a physiotherapist.
  • at high-risk for adverse neurological outcomes as considered by the pediatrician on the basis of clinical judgement (example: serious asphyxia, prematurity, stroke, brain hemorrhage)

Exclusion Criteria

  • Peripheral neuromotor disease e.g. brachial plexus injury
  • iatrogenic restricted movements (e.g. cast for clubfoot)

Outcomes

Primary Outcomes

Predictability of GMA and computer-based assessment for development of CP

Time Frame: 5 years

Correlation of computer software data between standard video set-up and handheld smartphone video.

Time Frame: 1 week

Scorable video for remote GMA

Time Frame: 1 week

Study Sites (3)

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