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Clinical Trials/NCT03106493
NCT03106493
Completed
Not Applicable

Upstate New York Infant Development Screening Program

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)0 sites6,171 target enrollmentJuly 1, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Enrollment
6171
Primary Endpoint
Blood Pressure
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The goal of the Upstate KIDS Study is to track the growth, development and long-term health of children given the increasing use of infertility treatment, occurrence of maternal obesity and pregnancy complications, and rising maternal age at birth.

Detailed Description

The Upstate KIDS Study aims to determine if there are differences in health measures between children conceived by infertility treatment and children conceived naturally. In the first phase of the study, the focus was on growth and development through age 3 years. In the second phase of the study, the focus is turning to cardiometabolic factors through age 9 years. Infertility treatments include assisted reproductive technologies (ART) such as in vitro fertilization (IVF), controlled ovarian hyperstimulation (COH) and ovulation induction (OI). The study was originally designed as a matched exposure cohort. Specifically, singletons whose birth certificates indicated the use of infertility treatment were considered 'exposed' singleton infants and subsequently frequency-matched on perinatal region of birth at a ratio of 1:3 to 'unexposed' singletons. Twins and higher order multiples were invited to participate regardless of mode of conception. Mothers and their newborns were recruited approximately 2-4 months postpartum. The first phase of the study was completed in 2014 and main findings can be found under publications. The second phase objectives are: To determine whether infertility treatment is associated with differences in growth and development from age 6 to 8 years with particular focus on childhood cardio-metabolic outcomes by follow-up of children conceived by ART or other infertility treatments and children who were conceived without treatment. Secondarily, to assess epigenetic differences as measured by DNA methylation using collected biospecimens.

Registry
clinicaltrials.gov
Start Date
July 1, 2008
End Date
November 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Mothers delivering a live birth in New York State (excluding New York City).

Exclusion Criteria

  • Refused follow-up

Outcomes

Primary Outcomes

Blood Pressure

Time Frame: Through age 9 years

Measurement of blood pressure

Secondary Outcomes

  • Motor milestone development(4-24 months)

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