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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04098679
Other study ID # REB14-2146_MOD2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 30, 2019
Est. completion date December 31, 2023

Study information

Verified date September 2022
Source University of Calgary
Contact Sonya Mergler, BA
Phone 416-480-5627
Email conceptt@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a follow-up study of children born to mothers who participated in the CONCEPTT Trial. CONCEPTT (a multicentre randomized controlled trial of continuous glucose monitoring (CGM) in women with Type 1 diabetes during pregnancy). The purpose of this study is to examine the association of maternal glycemic measures on childhood intelligence quotient (IQ), behavioural outcomes, language scores and weight measures. The children of the women who participated in CONCEPTT will be assessed.


Description:

The assessments will occur between the children's ages of 3-7 years. The assessment will include obtaining consent and child measurements including weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated. The other procedures will include: 1. the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (1); 2. ADHD Rating Scale IV (2) and ADHD Rating Scale-IV Preschool Version (3); 3. Social Responsiveness Scale-2 for ASD behaviours (4); 4. Children's performance on the Speed Naming and Phonological Processing subscales of the NEPSY-II (5) 5. Parent reported language development on the Children's Communication Checklist-2 for children over four years of age (6) or the Language Use Inventory (LUI) for children 36 to 47 months of age (7). Basic demographic questions will be asked regarding the child's mother and father including age, ethnicity, education, occupation, family arrangement, presence of major illnesses, and diabetes complications. Questions regarding maternal diabetes, maternal and paternal family history of diabetes and risk factors for heart disease will be collected at the clinic visit.


Recruitment information / eligibility

Status Recruiting
Enrollment 174
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 7 Years
Eligibility Inclusion Criteria: - Children of women who participated in the CONCEPTT trial at selected recruiting sites. Exclusion Criteria: - Children (of women who participated in the CONCEPTT trial) with major congenital anomalies will be assessed on a case by case basis to determine eligibility.

Study Design


Locations

Country Name City State
Canada University of Calgary Calgary Alberta
Canada Lawson Health Research Institute London Ontario
Canada Mount Sinai Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
University of Calgary Juvenile Diabetes Research Foundation, SRI International

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPT — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary IQ IQ assessed by the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) 2 years
Secondary ADHD Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-IV and Attention Deficit Hyperactive Disorder Rating Scale-IV Preschool Version. It is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms. The respondent rates each item on a scale of 0 (not at all) to 3 (very often).
The scale yields scores for an Inattentive, Hyperactive/Impulsive and Total Scale. The subscales are Inattention Factor and Hyperactive/Impulsive Factor.
2 years
Secondary ASD Social Responsiveness Scale-2 questionnaire results for Autism Spectrum Disorder behaviours. It is an 65-item questionnaire that requires the respondent to describe the child's behaviour. The respondent rates each item on a scale of 1 (not true) to 4 (almost always true). The scale yields scores for autism spectrum disorders for total score discussion of social behaviour and social interactions. 2 years
Secondary NEPSY-II The NEPSY-II stands for "A Developmental NEuroPSYchological Assessment". Children's language skills assessed using the Speed Naming and Phonological Processing subscales of the NEPSY-II testing results. Phonological Processing is a subtest composed of phonological processing tasks designed to assess phonemic awareness. Speed Naming is a timed subtest designed to assess rapid semantic access to and production of names of colors, shapes, sizes, letters, or numbers. 2 years
Secondary CCC-2/LUI Parent reported language development on the Children's Communication Checklist-2 (CCC_2) for children over four years of age or the Language Use Inventory (LUI) for children 36 to 47 months of age questionnaire results. The Children's Communication Checklist - Seconda Edition has 70 Statements that refer to difficulties children may have that affect their ability to communicate. Rating key is 0 (less than once a week or never) to 3 (several times, more than twice, a day, or always). Total score is used. 2 years
Secondary Demographics Data form to be completed by parents will ask about their level of education, sex, gender, socioeconomic status, height, and any neurodevelopmental or other medical diagnoses in their enrolled child 2 years
Secondary Adiposity Childhood adiposity measures: weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated using standardized procedures 2 years
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