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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07141654

Enrollment

100

Registered

2025-08-26

Start date

2025-10-01

Completion date

2028-02-29

Last updated

2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, General Movement Assessment, Prematurity

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 29 Weeks

Healthy volunteers

Yes

Inclusion criteria

1. 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 2. Parents can communicate in French or English 3. Intention to come for regular follow-up in the MCH Neonatal Clinic and/or Physical/Occupational therapy appointments

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Score at the Prechtl Qualitative General Movements Assessment	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

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

Outcome results