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Not yet recruitingNCT07141654Updated Oct 7, 2025

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

An observational study in Cerebral Palsy, General Movement Assessment and Prematurity, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Not yet recruiting. Open to participants aged Up to 29 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-07.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
Up to 29 Weeks
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Palsy
  • General Movement Assessment
  • Prematurity
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 100 is above the median of 63 across 455 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 29 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Newborns \< 29 weeks gestation admitted to the MCH NICU, who are anticipated to be followed at the MCH Neonatal Follow-up Clinic

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
18 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Score at the Prechtl Qualitative General Movements Assessment

    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

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

Secondary outcomes

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

    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.

    Time frame: From enrollment up to 18 months corrected age

  2. Assess age at referral

    to assess the age at referral for community rehabilitation services for infants with GMA early signs of CP using patient electronic charts

    Time frame: From enrollment up to 18 months corrected age

  3. Assess parental satisfaction using a feedback questionnaire

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

    Time frame: From enrollment up to 18 months corrected age

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07141654
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible party
Jarred Garfinkle (Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Aug 26, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Oct 7, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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