Active — Not RecruitingNot Applicable

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

Norway100 participantsStarted 2020-08-03

Plain-language 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.

Who can participate

Age range

0 Months – 2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Scorable video for remote GMA

Timeframe: 1 week

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

Timeframe: 1 week

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

Timeframe: 2 years

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

Timeframe: 5 years

Trial details

NCT IDNCT04287166

SponsorSt. Olavs Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

0 Months – 2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Scorable video for remote GMA

Timeframe: 1 week

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

Timeframe: 1 week

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

Timeframe: 2 years

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

Timeframe: 5 years