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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

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
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

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

Estimated Enrollment: 134
Study Start Date: September 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 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.

  Eligibility

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.

Criteria

Inclusion Criteria:

  • Preterm Infant
  • Very low birth weight or extremerly 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 ClinicalTrials.gov identifier: NCT01430832

Contacts
Contact: Lidia Gabis, MD +972-3-5302236 lidia.gabis@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Lidia Gabis, MD    +972-3-5302236    lidia.gabis@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
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
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01430832     History of Changes
Other Study ID Numbers: SHEBA-10-8121-LG-CTIL
Study First Received: September 7, 2011
Last Updated: March 1, 2013
Health Authority: Israel: Israel ministry of health

Keywords provided by Sheba Medical Center:
PTSD
Preterm
Premature
VLBW

Additional relevant MeSH terms:
Birth Weight
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Body Weight
Mental Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014