Cerebral PalsyNCT07141654
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 of Cerebral Palsy and General Movement Assessment, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 29 weeksHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, General Movement Assessment, Prematurity
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to Feb 2028
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 29 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns < 29 weeks gestation admitted to the MCH NICU, who are anticipated to be followed at the MCH Neonatal Follow-up Clinic
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: Empowering Families in Early Detection: Implementing Family-Led Recording for Early Diagnosis of Cerebral Palsy in Preterm Infants
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.
- Conditions
- Cerebral Palsy, General Movement Assessment, Prematurity
- Medical subject headings
- Cerebral Palsy, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment up to the 18 months corrected age
Secondary outcomes (3)
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.
Measured: From enrollment up to 18 months corrected age
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
Measured: From enrollment up to 18 months corrected age
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
Measured: From enrollment up to 18 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jarred Garfinkle, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141654
- Sponsor's protocol ID
- 2026-11839
- Status last verified
- Oct 2025
- First submitted
- 18 Aug 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Families in Early Detection: Implementing Family-Led Recording for Early Diagnosis of Cerebral Palsy in Preterm Infants
- ClinicalTrials.gov ID
- NCT07141654
- Acronym / sponsor ID
- 2026-11839
- Conditions
- Cerebral Palsy, General Movement Assessment, Prematurity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- Up to 29 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns < 29 weeks gestation admitted to the MCH NICU, who are anticipated to be followed at the MCH Neonatal Follow-up Clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 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
Assess age at referral
Time frame: From enrollment up to 18 months corrected age
Assess parental satisfaction using a feedback questionnaire
Time frame: From enrollment up to 18 months corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and General Movement Assessment, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score at the Prechtl Qualitative General Movements Assessment (time frame: From enrollment up to the 18 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.