Gestational Diabetes Mother-infant Cohort

Cognitive Impairment Clinical Trial

Official title:

A Cohort Study on the Impact of Gestational Blood Glucose Management and Postnatal Nurturing Environment on Delayed Language Development in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021691
• Other study ID #: NCRCCHD-2022-GP-17
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: August 2023
• Source: Gansu Provincial Maternal and Child Health Care Hospital
• Contact: Yanxia Wang, Dr.
• Phone: 86-0931-5188689
• Email: 1091771450[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children. The study investigated the results of blood glucose screening during pregnancy for the children's mothers, and followed up on the blood glucose management effectiveness of pregnant women with abnormal blood glucose levels before delivery. Participants will be also surveyed the "S-S method for language development assessment, "gsell Scale", and "0-6 year-old family nurturing environment evaluation scale" to evaluate the language development and family nurturing environment.

Description:

Glucose management during pregnancy and the postnatal nurturing environment are keys to early detection and early intervention of language delay, which is important to reduce abnormal language development in children. In this study, mothers diagnosed with gestational diabetes mellitus in the department of hospital and offspring were used as participants. The investigators take a follow-up visit to participants' offspring using the S-S method of language development assessment, gsell Infant and Toddler Development Scale, and 0-6 years old family parenting environment evaluation scale. The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

Inclusion Criteria:

• Children 1.5-2.5 years old with no serious underlying diseases and no hearing impairment.

Exclusion Criteria:

• diagnosed hearing impairment, organic dysarthria, oral disease; (ii) cerebral palsy;

• neurological and hereditary metabolic diseases; (iv) deaf father/mother.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Cohort Study
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Behavioral:
• Acquired nurturing environment
Superimposed effects of intrauterine high-sugar environment exposure and postnatal nurturing environment exposure

Locations

Country	Name	City	State
China	GansuPMCH	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Gansu Provincial Maternal and Child Health Care Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delayed language development in children	"Number of participants diagnosed with GDM," "Number of offspring of participants who participated in the survey of family nurturing environments," and "Composition ratio of offspring with GDM who presented with language delays."	2023.1-2025.11