Upstate New York Infant Development Screening Program

NCT ID: NCT03106493

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-01

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Obesity Blood Pressure Motor Delay Developmental Delay Asthma Allergies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary

Singletons and 1 twin of each pair

None (observational)

Intervention Type OTHER

None (observational)

Secondary

Twin sibling of children enrolled in primary cohort

None (observational)

Intervention Type OTHER

None (observational)

Tertiary

Higher order multiples and siblings

None (observational)

Intervention Type OTHER

None (observational)

Interventions

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None (observational)

None (observational)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Refused follow-up
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York State Department of Health

OTHER_GOV

Sponsor Role collaborator

University at Albany

OTHER

Sponsor Role collaborator

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

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 24665916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24333851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25813287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26746435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27165624 (View on PubMed)

Clayton PK, Putnick DL, Trees IR, Robinson SL, O'Connor TG, Tyris JN, Yeung EH. Age of Juice Introduction and Cardiometabolic Outcomes in Middle Childhood. J Nutr. 2024 Aug;154(8):2514-2523. doi: 10.1016/j.tjnut.2024.06.014. Epub 2024 Jun 26.

Reference Type DERIVED
PMID: 38936550 (View on PubMed)

Polinski KJ, Robinson SL, Putnick DL, Sundaram R, Ghassabian A, Joseph P, Gomez-Lobo V, Bell EM, Yeung EH. Maternal self-reported polycystic ovary syndrome with offspring and maternal cardiometabolic outcomes. Hum Reprod. 2024 Jan 5;39(1):232-239. doi: 10.1093/humrep/dead227.

Reference Type DERIVED
PMID: 37935839 (View on PubMed)

Yeung EH, Mendola P, Sundaram R, Lin TC, Broadney MM, Putnick DL, Robinson SL, Polinski KJ, Wactawski-Wende J, Ghassabian A, O'Connor TG, Gore-Langton RE, Stern JE, Bell E. Conception by fertility treatment and cardiometabolic risk in middle childhood. Fertil Steril. 2022 Aug;118(2):349-359. doi: 10.1016/j.fertnstert.2022.04.030. Epub 2022 Jun 10.

Reference Type DERIVED
PMID: 35697532 (View on PubMed)

Michels KA, Ghassabian A, Mumford SL, Sundaram R, Bell EM, Bello SC, Yeung EH. Breastfeeding and motor development in term and preterm infants in a longitudinal US cohort. Am J Clin Nutr. 2017 Dec;106(6):1456-1462. doi: 10.3945/ajcn.116.144279. Epub 2017 Nov 1.

Reference Type DERIVED
PMID: 29092884 (View on PubMed)

Other Identifiers

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HHSN275201400013C

Identifier Type: -

Identifier Source: org_study_id

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