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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01430832
First received: September 7, 2011
Last updated: March 1, 2013
Last verified: March 2013

September 7, 2011
March 1, 2013
September 2011
November 2013   (final data collection date for primary outcome measure)
Not relevant [ Time Frame: Not relevant ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01430832 on ClinicalTrials.gov Archive Site
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Developmental Outcomes of Extreme Prematurity: Correlations With Maternal Post-Traumatic Symptoms, Parental Stress and Post-Traumatic Growth, 5-15 Years Postpartum
The Long-Term Developmental Outcomes of Extreme Prematurity: Correlations With Maternal Post-Traumatic Symptoms, Parental Stress and Post-Traumatic Growth, 5-15 Years Postpartum

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.

Medical records of the children will be used for information in four categoris: prenatal, birth, development,and demographic information. Parents will be contacted and interviewed regarding the child's development. In addition, they will complete the following questionnares: PPQ-II Perinatal PTSD Questionnaire- modified, PTGI -The Posttraumatic Growth Inventory,Parental Stress Index- Short Form- PSI-SF, and Life Events questionnare.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Preterm Infants
  • Post Traumatic Stress Disorder
  • Emotional Stress
  • Infant, Very Low Birth Weight
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
134
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Missing information regarding birth week and weight
Both
Not Provided
No
Contact: Lidia Gabis, MD +972-3-5302236 lidia.gabis@sheba.health.gov.il
Israel
 
NCT01430832
SHEBA-10-8121-LG-CTIL
No
Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Lidia Gabis, MD Sheba Medical Center
Principal Investigator: Gabi Zerach, Ph.D Ariel University Center of Samaria
Study Director: Shefer Shahar, Ph.D Sheba Medical Center
Study Director: Adi Elsing, BA Sheba Medical Center
Sheba Medical Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP