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Clinical Trials in Spain / NCT05754567
Recruiting Observational

CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes

NCT05754567 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Manitoba
Phase
Observational
Started
2023-09-07
Last updated
2026-03-20

Condition(s) studied

Neurocognitive Disorders

Study summary

Neurodevelopmental Outcomes among Offspring of women with Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial (CONCEPTT Kids International). An international, multicentre prospective cohort study of child and mother pairs. The potential number of recruits is 225 and the main inclusion criteria is child's mother who participated in the CONCEPTT Trial.

Eligibility

Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Children of women who participated in the CONCEPTT trial at selected recruiting sites Exclusion Criteria: * NA

Primary outcome measure(s)

  • Childhood executive function — 15 minutes
    The BRIEF2 (Behaviour Rating Inventory of Executive Function - Second Edition) is a parent-report 63 item questionnaire will be utilized to measure of executive function in school-aged children and adolescents (5-18 years of age). The BRIEF2 (Behaviour Rating Inventory of Executive Function - Second Edition) provides three broad index scores (i.e., Behaviour Regulation, Emotional Regulation, and Cognitive Regulation) and a General Executive Composite score. Results are provided in the form of T scores (mean=50, SD=10) with higher scores indicative of greater executive function difficulties; T scores of 65 are considered clinically elevated and indicative of executive function deficits.

Trial sites (10)

FacilityCityRegionStatus
Alberta Health Services Calgary Alberta Recruiting
IWK Health Halifax Nova Scotia Recruiting
The Ottawa Hospital - Riverside Campus Ottawa Ontario Recruiting
Mt Sinai Hospital Toronto Ontario Not Yet Recruiting
Hospital de la Santa Creu Barcelona Spain Recruiting
NHS Lothian Royal Infirmary of Edinburgh Edinburgh Scotland Recruiting
Glasgow Royal Infirmary Glasgow United Kingdom Recruiting
Ipswich Hospital NHS Trust Ipswich United Kingdom Recruiting
St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust Leeds United Kingdom Recruiting
Southampton General Hospital Southampton United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05754567 on ClinicalTrials.gov ↗ ← All trials in Spain