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NCT01430832 Clinical Trial

Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

Post Traumatic Stress Disorder Clinical Trial

Official title:
The Long-Term Developmental Outcomes of Extreme Prematurity: Correlations With Maternal Post-Traumatic Symptoms, Parental Stress and Post-Traumatic Growth, 5-15 Years Postpartum

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01430832
Other study ID # SHEBA-10-8121-LG-CTIL
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 1, 2011
Est. completion date November 2011

Study information
Verified date June 2018
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 95
Est. completion date November 2011
Est. primary completion date November 1, 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Preterm Infant

- Very low birth weight or extremely low birth weight

Exclusion Criteria:

- Missing information regarding birth week and weight

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Not relevant Not relevant
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