NCT07141654

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Oct 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Oct 2025Feb 2028

First Submitted

Initial submission to the registry

August 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

August 18, 2025

Last Update Submit

October 1, 2025

Conditions

Cerebral PalsyGeneral Movement AssessmentPrematurity

Outcome Measures

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

    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

    From enrollment up to 18 months corrected age

  • Assess age at referral

    From enrollment up to 18 months corrected age

  • Assess parental satisfaction using a feedback questionnaire

    From enrollment up to 18 months corrected age

Eligibility Criteria

AgeUp to 29 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral PalsyPremature Birth

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 26, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

October 7, 2025

Record last verified: 2025-10