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Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

Sponsor
Sheba Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01430832
Collaborator
(none)
95
Enrollment
1
Location
2
Duration (Months)
47.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Sep 1, 2011
    Actual Primary Completion Date :
    Nov 1, 2011
    Actual Study Completion Date :
    Nov 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Not relevant [Not relevant]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center Ramat Gan Israel

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT01430832
    Other Study ID Numbers:
    • SHEBA-10-8121-LG-CTIL
    First Posted:
    Sep 8, 2011
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Sheba Medical Center
    PTSD
    Preterm
    Premature
    VLBW
    Additional relevant MeSH terms:
    Birth Weight
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Jul 2, 2018