Upstate New York Infant Development Screening Program | NCT03106493

Studies
Upstate New York Infant Development Screening Program

NCT03106493

Sponsor

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

Status

Completed

Last Update Posted

Mar 3, 2021Actual

Enrollment

6,171Actual

Phase

Not provided

Conditions

Obesity
Blood Pressure
Motor Delay
Developmental Delay
Asthma
Allergies

Interventions

None (observational)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2008Actual

Primary Completion Date

Nov 2019Actual

Completion Date

Nov 2019Actual

First Submitted Date

Apr 4, 2017

First Submission Date that Met QC Criteria

Apr 4, 2017

First Posted Date

Apr 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2021

Last Update Posted Date

Mar 3, 2021Actual

Name	Class
New York State Department of Health	OTHER_GOV
University at Albany	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

6,171Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
None (observational)	Other	None (observational)	Primary Secondary Tertiary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Pressure	Measurement of blood pressure	Through age 9 years

Secondary Outcomes

Measure	Description	Time Frame
Motor milestone development	Study collected information using questionnaires to mothers with aid of journal	4-24 months

Other Outcomes

Measure	Description	Time Frame
Breastfeeding information	Study collected information using questionnaires to mothers	4-12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Refused follow-up

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24665916	Background	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.
24333851

ID	Term
D009765	Obesity
D011596	Psychomotor Disorders
D007859	Learning Disabilities
D001249	Asthma
D006967	Hypersensitivity

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases