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NCT00332150 Clinical Trial

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

Parents Approval to Research Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00332150
Other study ID # SHEBA-06-4076-AM-CTIL
Secondary ID
Status Completed
Phase N/A
First received May 31, 2006
Last updated January 23, 2013
Start date March 2006
Est. completion date June 2006

Study information
Verified date January 2013
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation