- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332150
Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns
January 23, 2013 updated by: Sheba Medical Center
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayala Maayan, Dr., Sheba Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zupancic JA, Gillie P, Streiner DL, Watts JL, Schmidt B. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics. 1997 Jan;99(1):E6. doi: 10.1542/peds.99.1.e6.
- Maayan-Metzger A, Kedem-Friedrich P, Kuint J. Motivations of mothers to enroll their newborn infants in general clinical research on well-infant care and development. Pediatrics. 2008 Mar;121(3):e590-6. doi: 10.1542/peds.2007-1571.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
May 31, 2006
First Submitted That Met QC Criteria
May 31, 2006
First Posted (Estimate)
June 1, 2006
Study Record Updates
Last Update Posted (Estimate)
January 24, 2013
Last Update Submitted That Met QC Criteria
January 23, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SHEBA-06-4076-AM-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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