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

NCT ID: NCT04287166

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-03

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

0 Months

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alesund Hospital

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lise Støylen

Role: STUDY_DIRECTOR

St Olavs Hospital, Clinic of Clinical Services

Torstein Rø IKOM

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology, IKOM

Locations

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Department of Pediatrics, Møre and Romsdal Hospital Trust

Ålesund, , Norway

Site Status

Department of Pediatrics, Nord-Trøndelag Hospital Trust

Levanger, , Norway

Site Status

Department of Pediatrics, St. Olav's Hospital Trust

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Adde L, Aberg KB, Fjortoft T, Grunewaldt KH, Lade R, Osland S, Piegsa F, Sandstrom PG, Stoen R, Storvold GV, Eriksen BH. Implementation of remote general movement assessment using the in-motion instructions in a high-risk norwegian cohort. BMC Pediatr. 2024 Jul 10;24(1):442. doi: 10.1186/s12887-024-04927-4.

Reference Type DERIVED
PMID: 38987721 (View on PubMed)

Other Identifiers

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REK 62240

Identifier Type: -

Identifier Source: org_study_id

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