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

NCT ID: NCT00332150

Last Updated: 2013-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Parents Approval to Research

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sehba Medical Center

Principal Investigators

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Ayala Maayan, Dr.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 9096174 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18310179 (View on PubMed)

Other Identifiers

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SHEBA-06-4076-AM-CTIL

Identifier Type: -

Identifier Source: org_study_id

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