Upstate KIDS: Upstate New York Infant Development Screening Program

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
Overall Status
Completed
CT.gov ID
NCT03106493
Collaborator
New York State Department of Health (Other), University at Albany (Other)
6,171
136

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: None (observational)

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.

Study Design

Study Type:
Observational
Actual Enrollment :
6171 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Upstate New York Infant Development Screening Program
Actual Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Primary

Singletons and 1 twin of each pair

Other: None (observational)
None (observational)

Secondary

Twin sibling of children enrolled in primary cohort

Other: None (observational)
None (observational)

Tertiary

Higher order multiples and siblings

Other: None (observational)
None (observational)

Outcome Measures

Primary Outcome Measures

  1. Blood Pressure [Through age 9 years]

    Measurement of blood pressure

Secondary Outcome Measures

  1. Motor milestone development [4-24 months]

    Study collected information using questionnaires to mothers with aid of journal

Other Outcome Measures

  1. Breastfeeding information [4-12 months]

    Study collected information using questionnaires to mothers

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Mothers delivering a live birth in New York State (excluding New York City).
Exclusion Criteria:
  • Refused follow-up

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • New York State Department of Health
  • University at Albany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT03106493
Other Study ID Numbers:
  • HHSN275201400013C
First Posted:
Apr 10, 2017
Last Update Posted:
Mar 3, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 3, 2021