Neurodevelopmental Outcomes of Preterm and Term Children | NCT02309697

Studies
Neurodevelopmental Outcomes of Preterm and Term Children

NCT02309697

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Terminated

Last Update Posted

Jan 14, 2016Estimated

Enrollment

1Actual

Phase

Not provided

Conditions

Development

Interventions

Not provided

Countries

United States

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study goals rolled into a broader study

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Dec 3, 2014

First Submission Date that Met QC Criteria

Dec 3, 2014

First Posted Date

Dec 5, 2014Estimated

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

Jan 13, 2016

Last Update Posted Date

Jan 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

This research will be completed at Mount Sinai Hospital. All participants will be identified from Mount Sinai Hospital records of infants born at MSH and/or cared for in the Mount Sinai NICU on or after January 1, 2011, at full term or preterm. The study team will contact the parents of eligible potential participants by telephone to explain the study and ask if the parent will consent to their child's participation. If the parent agrees, we will make an appointment for the child to come to Mount Sinai for the evaluation using the Bayley-III. The parents will be mailed the study consent form, a fact sheet with information about the study, and the CBCL to complete before they bring their child to their appointment. Mount Sinai records from the birth hospitalization will be reviewed for the birth history and medical comorbidities. Mount Sinai medical records of the mother's obstetric care will also be accessed to obtain medical history from the pregnancy. If a participating child has received outpatient care at Mount Sinai, the investigators will access their record in Epic to obtain scores from previous developmental assessments and records of medical comorbidities. If they have not attended the Mount Sinai clinic, but have received outpatient care elsewhere, the parents will be asked to provide contact information for their pediatrician, and for permission to obtain their child's records.

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

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Full Term		Children born at full term on or after Jan 1, 2011
PreTerm		Children born preterm on or after Jan 1, 2011

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Bayley Scales of Development III (BayleyIII)	The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) is used to measure developmental and behavioral outcomes. The Bayley-III is a standardized assessment of cognitive, motor, and language development administered by a trained researcher. The Bayley-III also includes social and emotional development questionnaire that is completed by a primary caregiver.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-English speaking

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

42 Months

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annemarie Stroustrup, MD, MPH	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10029	United States

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

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