Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

NCT ID: NCT01430832

Last Updated: 2018-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-01

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Development

The infant's development level will be assessed using a phone interview with parents

No interventions assigned to this group

Abnormal Development

The infant's level of development will be assessed using a phone interview with parents

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Preterm Infant
* Very low birth weight or extremely low birth weight

Exclusion Criteria

* Missing information regarding birth week and weight
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lidia Gabis, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Gabi Zerach, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ariel University

Shefer Shahar, Ph.D

Role: STUDY_DIRECTOR

Sheba Medical Center

Adi Elsing, BA

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-10-8121-LG-CTIL

Identifier Type: -

Identifier Source: org_study_id

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