Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00332150
First received: May 31, 2006
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

Parental approval to enroll their sick children in clinical research was studied. However, the motivation of parents to enroll healthy children and/or babies was not yet studied. The importance of clinical research among the healthy population is of extreme value. The aim of this study is to assess the motivation, medical trust and other factors influencing parents' decision to enroll their healthy baby in a clinical study.


Condition
Parents Approval to Research

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns

Further study details as provided by Sheba Medical Center:

Enrollment: 200
Study Start Date: March 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Mothers to either healthy full-term babies post delivery or preterms will be asked to anonymously answer a questionnaire. The questionnaire includes demographic data, questions regarding their approach to medical issues, factors that influence her to enroll her baby in a research trial (different research types, different benefits from the research and fears). Finally, the mother will be asked if she will be willing to enroll her baby to on-going studies in the department.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mothers to healthy newborns during hospital stay after delivery, and mothers of preterm infants during their hospitalization in NICU.

Exclusion Criteria:

  • Mothers of sick newborns (respiratory distress, receiving IV infusion, etc.) who are in the special care for newborns.
  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: NCT00332150

Locations
Israel
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ayala Maayan, Dr. Sheba Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ayala Maayan, Sehba Medical Center
ClinicalTrials.gov Identifier: NCT00332150     History of Changes
Other Study ID Numbers: SHEBA-06-4076-AM-CTIL
Study First Received: May 31, 2006
Last Updated: January 23, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
parents
newborn
clinical trials

ClinicalTrials.gov processed this record on October 19, 2014