Upstate New York Infant Development Screening Program (Upstate KIDS)

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Asthma; Obesity; Developmental Delay; Motor Delay; Blood Pressure; Allergies

Treatments: Other: None (observational)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03106493

HHSN275201400013C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,171 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Refused follow-up

Trial design

6,171 participants in 3 patient groups

Primary

Description:

Singletons and 1 twin of each pair

Treatment:

Other: None (observational)

Secondary

Description:

Twin sibling of children enrolled in primary cohort

Treatment:

Other: None (observational)

Tertiary

Description:

Higher order multiples and siblings

Treatment:

Other: None (observational)