Upstate New York Infant Development Screening Program

Obesity Clinical Trial

— Upstate KIDS  

Official title:

Upstate New York Infant Development Screening Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106493
• Other study ID #: HHSN275201400013C
• Status: Completed
• Start date: July 1, 2008
• Est. completion date: November 2019

Study information

• Verified date: March 2021
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6171
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Refused follow-up

Related Conditions & MeSH terms

• Allergies
• Asthma
• Blood Pressure
• Developmental Delay
• Motor Delay
• Obesity

Intervention

Other:
• None (observational)
None (observational)

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

References & Publications (5)

Andersen NJ, Mondal TK, Preissler MT, Freed BM, Stockinger S, Bell E, Druschel C, Louis GM, Lawrence DA. Detection of immunoglobulin isotypes from dried blood spots. J Immunol Methods. 2014 Feb;404:24-32. doi: 10.1016/j.jim.2013.12.001. Epub 2013 Dec 13. — View Citation

Buck Louis GM, Druschel C, Bell E, Stern JE, Luke B, McLain A, Sundaram R, Yeung E. Use of assisted reproductive technology treatment as reported by mothers in comparison with registry data: the Upstate KIDS Study. Fertil Steril. 2015 Jun;103(6):1461-8. doi: 10.1016/j.fertnstert.2015.02.033. Epub 2015 Mar 23. — View Citation

Buck Louis GM, Hediger ML, Bell EM, Kus CA, Sundaram R, McLain AC, Yeung E, Hills EA, Thoma ME, Druschel CM. Methodology for establishing a population-based birth cohort focusing on couple fertility and children's development, the Upstate KIDS Study. Paediatr Perinat Epidemiol. 2014 May;28(3):191-202. doi: 10.1111/ppe.12121. Epub 2014 Mar 25. — View Citation

Yeung EH, Sundaram R, Bell EM, Druschel C, Kus C, Ghassabian A, Bello S, Xie Y, Buck Louis GM. Examining Infertility Treatment and Early Childhood Development in the Upstate KIDS Study. JAMA Pediatr. 2016 Mar;170(3):251-8. doi: 10.1001/jamapediatrics.2015.4164. — View Citation

Yeung EH, Sundaram R, Bell EM, Druschel C, Kus C, Xie Y, Buck Louis GM. Infertility treatment and children's longitudinal growth between birth and 3 years of age. Hum Reprod. 2016 Jul;31(7):1621-8. doi: 10.1093/humrep/dew106. Epub 2016 May 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breastfeeding information	Study collected information using questionnaires to mothers	4-12 months
Primary	Blood Pressure	Measurement of blood pressure	Through age 9 years
Secondary	Motor milestone development	Study collected information using questionnaires to mothers with aid of journal	4-24 months