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Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

This study has been terminated.
Information provided by (Responsible Party):
Sheba Medical Center Identifier:
First received: September 7, 2011
Last updated: February 22, 2016
Last verified: February 2016
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Not relevant [ Time Frame: Not relevant ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: September 2011
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
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

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.

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are children born at Sheba Medical center between the years 1995-2006.

Inclusion Criteria:

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

Exclusion Criteria:

  • Missing information regarding birth week and weight
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01430832

Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Lidia Gabis, MD Sheba Medical Center
Principal Investigator: Gabi Zerach, Ph.D Ariel University
Study Director: Shefer Shahar, Ph.D Sheba Medical Center
Study Director: Adi Elsing, BA Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center Identifier: NCT01430832     History of Changes
Other Study ID Numbers: SHEBA-10-8121-LG-CTIL 
Study First Received: September 7, 2011
Last Updated: February 22, 2016
Health Authority: Israel: Israel ministry of health
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Sheba Medical Center:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Birth Weight
Premature Birth
Stress, Psychological
Trauma and Stressor Related Disorders
Mental Disorders
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Behavioral Symptoms processed this record on October 27, 2016