Early Remote At-risk Diagnosis for Cerebral Palsy in Follow-up Clinics for High-risk Infants

Cerebral Palsy Clinical Trial

— In-Motion  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04287166
• Other study ID #: REK 62240
• Status: Active, not recruiting
• Start date: August 3, 2020
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Gender: All
• Age group: 0 Months to 2 Months

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Norway	Department of Pediatrics, Møre and Romsdal Hospital Trust	Ålesund
Norway	Department of Pediatrics, Nord-Trøndelag Hospital Trust	Levanger
Norway	Department of Pediatrics, St. Olav's Hospital Trust	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Alesund Hospital, Helse Nord-Trøndelag HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scorable video for remote GMA		1 week
Primary	Correlation of computer software data between standard video set-up and handheld smartphone video.		1 week
Primary	Predictability of GMA and computer-based assessment for development of CP		2 years
Primary	Predictability of GMA and computer-based assessment for development of CP		5 years