NCT03106493

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,171

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

11.3 years

First QC Date

April 4, 2017

Last Update Submit

March 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Measurement of blood pressure

    Through age 9 years

Secondary Outcomes (1)

  • Motor milestone development

    4-24 months

Other Outcomes (1)

  • Breastfeeding information

    4-12 months

Study Arms (3)

Primary

Singletons and 1 twin of each pair

Other: None (observational)

Secondary

Twin sibling of children enrolled in primary cohort

Other: None (observational)

Tertiary

Higher order multiples and siblings

Other: None (observational)

Interventions

None (observational)

PrimarySecondaryTertiary

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Exposure enriched cohort as described: 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. Paediatric and Perinatal Epidemiology. 2014 May;28(3):191-202.

You may qualify if:

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

You may not qualify if:

  • Refused follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 24665916BACKGROUND
  • 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.

    PMID: 24333851BACKGROUND
  • 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.

    PMID: 25813287BACKGROUND
  • 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.

    PMID: 26746435BACKGROUND
  • 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.

    PMID: 27165624BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, urine, saliva (in subgroup under ongoing future work)

MeSH Terms

Conditions

ObesityPsychomotor DisordersLearning DisabilitiesAsthmaHypersensitivity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesCommunication DisordersNeurodevelopmental DisordersMental DisordersBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

July 1, 2008

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Data will be made available for public use by NIH data sharing system.