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

Completed

• Conditions: Parents Approval to Research

• Registration Number: NCT00332150
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-05-31
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Posted: 2006-06-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel