NCT02309697

Brief Summary

This study will utilize two validated tools for assessing child development and behavior, to investigate the outcomes for children born preterm compared with those born at full term. Two hundred children born or cared for during the neonatal period at Mount Sinai Hospital will be enrolled. Parents will be asked to complete a behavioral assessment questionnaire, and which will assess development in an examination administered by a trained occupational therapist at Mount Sinai Hospital.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

December 3, 2014

Last Update Submit

January 13, 2016

Conditions

Development

Keywords

DevelopmentAssessmentsPremature birth

Outcome Measures

Primary Outcomes (1)

  • Child Behavior Checklist (CBCL)

    The CBCL, completed by a primary caregiver, is a standardized assessment of behavioral problems categorized into externalizing or internalizing behaviors.

    day 1

Secondary Outcomes (1)

  • Bayley Scales of Development III (BayleyIII)

    day 1

Study Arms (2)

Full Term

Children born at full term on or after Jan 1, 2011

PreTerm

Children born preterm on or after Jan 1, 2011

Eligibility Criteria

Age6 Months - 42 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

200 children born on or after January 1, 2011 at Mount Sinai or admitted to the Mount Sinai Hospital for newborn care.

You may qualify if:

  • Born on or after January 1, 2011
  • Admitted to the Mount Sinai Hospital for newborn care

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Annemarie Stroustrup, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

US(1)