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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332150
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : January 24, 2013
Information provided by:
Sheba Medical Center

Brief Summary:
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 or disease
Parents Approval to Research

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns
Study Start Date : March 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332150

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Ayala Maayan, Sehba Medical Center Identifier: NCT00332150    
Other Study ID Numbers: SHEBA-06-4076-AM-CTIL
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013
Keywords provided by Sheba Medical Center:
clinical trials