Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01430832
Recruitment Status : Terminated
First Posted : September 8, 2011
Last Update Posted : February 23, 2016
Information provided by (Responsible Party):
Sheba Medical Center

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.

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

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.

Study Type : Observational
Actual Enrollment : 95 participants
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
Study Start Date : September 2011
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

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

Primary Outcome Measures :
  1. Not relevant [ Time Frame: Not relevant ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Sheba Medical Center Identifier: NCT01430832     History of Changes
Other Study ID Numbers: SHEBA-10-8121-LG-CTIL
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sheba Medical Center:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Birth Weight
Stress, Psychological
Trauma and Stressor Related Disorders
Mental Disorders
Body Weight
Signs and Symptoms
Behavioral Symptoms