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

May 31, 2006
January 23, 2013
March 2006
June 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00332150 on ClinicalTrials.gov Archive Site
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Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns
Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Parents Approval to Research
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2006
June 2006   (final data collection date for primary outcome measure)

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.
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00332150
SHEBA-06-4076-AM-CTIL
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Dr. Ayala Maayan, Sehba Medical Center
Sheba Medical Center
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Principal Investigator: Ayala Maayan, Dr. Sheba Medical Center
Sheba Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP