Clinical trial NCT04287166: Early Remote At-risk Diagnosis for Cerebral Palsy in Follow-up Clinics for High-risk Infants
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cerebral Palsy
Keywords: Diagnosis
Videos
Smartphone app
Movement
Movement disorders
Infants
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Alesund Hospital
name: Helse Nord-Trøndelag HF
First posted: 2020-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High-risk infants referred to high-risk follow-up at discharge from one of the participating Neonatal Intensive Care Units, are candidates for enrollment. Following review of the inclusion and exclusion criteria, eligible subjects will be invited to participate. All subjects (parents) must give written informed consent prior to any study procedures being carried out.

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.


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)

Primary outcomes:
measure: Scorable video for remote GMA
timeFrame: 1 week
measure: Correlation of computer software data between standard video set-up and handheld smartphone video.
timeFrame: 1 week
measure: Predictability of GMA and computer-based assessment for development of CP
timeFrame: 2 years
measure: Predictability of GMA and computer-based assessment for development of CP
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Department of Pediatrics, Nord-Trøndelag Hospital Trust
city: Trondheim
country: Norway
facility: Department of Pediatrics, St. Olav's Hospital Trust
city: Ålesund
country: Norway
facility: Department of Pediatrics, Møre and Romsdal Hospital Trust
Study officials:
affiliation: St Olavs Hospital, Clinic of Clinical Services
name: Lise Støylen
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology, IKOM
name: Torstein Rø IKOM
role: STUDY_DIRECTOR
References: