NCT01430832

Terminated

Developmental Outcomes of Extreme Prematurity, 5-15 Years Po...

Sheba Medical Center Source

Sheba Medical Center

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

SHEBA-10-8121-LG-CTIL

Study Type

observational

Actual enrollment (reported)

95

Locations

1 country

Sites

1

Timeline

Study Start

September 1, 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 1, 2011

Actual (reported)

Study Completion

November 2011

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 95 participants
Study completion date: November 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 1, 2011
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 7, 2011
Actual (reported)
First Posted
September 8, 2011
Actual (reported)
Study Completion
November 2011
Actual (reported)
Primary Completion
November 1, 2011
Actual (reported)

Last Updated: July 2, 2018
Status Verified: June 2018
Last Update Submitted: June 28, 2018

Conditions

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

Keywords

PTSDPretermPrematureVLBW

Outcome Measures

Primary Outcomes (1)

Not relevant
Not relevant

Study Arms (2)

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

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Preterm Infant

Sponsors & Collaborators

Sheba Medical Center
Governmentlead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticStress, PsychologicalPremature Birth

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

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

Enrollment

95 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 8, 2011

Study Start

September 1, 2011

Date type not reported

This date has not been verified as actual or estimated.

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Withdrawn

NCT01233908

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Completed

NCT01325168

The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With Post Traumatic Stress Disorder (PTSD)

Phase 4Completed

NCT01140243

Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital

Not ApplicableCompleted

Very low birth weight or extremely low birth weight

You may not qualify if:

Missing information regarding birth week and weight

Contact the study team to confirm eligibility.

Primary Completion

November 1, 2011

Actual (reported)

Study Completion

November 2011

Actual (reported)

Last Updated

July 2, 2018

Record last verified: 2018-06

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01430832
Data provider: ClinicalTrials.gov
Source updated: 2018-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:53 UTC

Locations

IL(1)

Study Stopped

Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Normal Development

Abnormal Development

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Normal Development

Abnormal Development

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations