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Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01430832
First received: September 7, 2011
Last updated: February 22, 2016
Last verified: February 2016

September 7, 2011
February 22, 2016
September 2011
November 2018   (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, 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 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.
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.
 
Terminated
95
November 2018
November 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Missing information regarding birth week and weight
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01430832
SHEBA-10-8121-LG-CTIL
No
Undecided
Not Provided
Sheba Medical Center
Sheba Medical Center
Not Provided
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
Sheba Medical Center
February 2016

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