Developmental Outcomes of Extreme Prematurity, 5-15 Years... | NCT01430832

Studies
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

NCT01430832

Sponsor

Sheba Medical Center

Status

Terminated

Last Update Posted

Jul 2, 2018Actual

Enrollment

95Actual

Phase

Not provided

Conditions

Preterm Infants
Post Traumatic Stress Disorder
Emotional Stress
Infant, Very Low Birth Weight

Interventions

Not provided

Countries

Israel

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

Jun 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment Status

Expanded Access Info

Start Date

Sep 1, 2011

Primary Completion Date

Nov 1, 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Sep 7, 2011

First Submission Date that Met QC Criteria

Sep 7, 2011

First Posted Date

Sep 8, 2011Estimated

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

Jun 28, 2018

Last Update Posted Date

Jul 2, 2018Actual

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

The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.

Detailed Description

Medical records of the children will be used for information in four categories: prenatal, birth, development,and demographic information. Parents will be contacted and interviewed regarding the child's development. In addition, they will complete the following questionnaires: PPQ-II Perinatal PTSD Questionnaire- modified, PTGI -The Posttraumatic Growth Inventory,Parental Stress Index- Short Form- PSI-SF, and Life Events questionnaire.

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

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal Development		The infant's development level will be assessed using a phone interview with parents
Abnormal Development		The infant's level of development will be assessed using a phone interview with parents

Interventions

Not provided

Measure	Description	Time Frame
Not relevant		Not relevant

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preterm Infant
Very low birth weight or extremely low birth weight

Exclusion Criteria:

Missing information regarding birth week and weight

Accepts Healthy Volunteers

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

Participants are children born at Sheba Medical center between the years 1995-2006.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lidia Gabis, MD	Sheba Medical Center	Principal Investigator
Gabi Zerach, Ph.D	Ariel University	Principal Investigator
Shefer Shahar, Ph.D	Sheba Medical Center	Study Director
Adi Elsing, BA	Sheba Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan			Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic
D013315	Stress, Psychological
D047928	Premature Birth

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided