This Study Aims to Evaluate the Validity of Family-led Recordings for General Movement Assessment (GMA) Compared to Provider-led Recording in Neonates Born Under 29weeks

This study aims to evaluate the validity of family-led recordings for General Movements Assessment (GMA) compared to provider-led recordings in neonates born <29 weeks.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Female Urogenital Diseases and Pregnancy Complications General Movement Assessment Nervous System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prematurity Urogenital Diseases

Age range

Up to 29 week

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newborns < 29 weeks gestation admitted to the Montréal Children's hospital (MCH) Neonatal Intensive Care Unit (NICU), who are anticipated to be followed at the MCH Neonatal Follow-up Clinic
Parents can communicate in French or English
Intention to come for regular follow-up in the MCH Neonatal Clinic and/or Physical/Occupational therapy appointments

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Score at the Prechtl Qualitative General Movements Assessment

Time frame: From enrollment up to the 18 months corrected age

evaluate the validity of family-led recordings for General Movement Assessment (GMA) compared to provider-led recordings in neonates born <29 weeks using the Prechtl Qualitative General Movements Assessment

Secondary outcomes

Measure prognostic value using local Canadian Neonatal Network (CNN) and Canadian Neonatal Follow Up Network (CNFUN) databases and electronic medical chart review

Time frame: From enrollment up to 18 months corrected age

to measure the prognostic value of the GMA in predicting Cerebral Palsy(CP) at 18 months corrected age. Information on patient characteristics and outcomes will be collected from the local Canadian Neonatal Network (CNN) and Canadian Neonatal Follow Up Network (CNFUN) databases for all infants meeting inclusion criteria. Additional data around GMA and neurodevelopment not included in the CNN/CNFUN databases will be collected through electronic medical chart review of all infants meeting inclusion criteria.
Assess age at referral

Time frame: From enrollment up to 18 months corrected age

to assess the age at referral for community rehabilitation services for infants with GMA early signs of CP using patient electronic charts
Assess parental satisfaction using a feedback questionnaire

Time frame: From enrollment up to 18 months corrected age

to assess the parental satisfaction with the GMA administration process and the training materials provided using a feedback questionnaire

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

Empowering Families in Early Detection: Implementing Family-Led Recording for Early Diagnosis of Cerebral Palsy in Preterm Infants

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Aug 26, 2025
Registry last updated: Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting