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Minor Increase Over Minimal Risk Research in NICU

NCT02482012 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 96

Last updated 2016-02-25

No results posted yet for this study

Summary

Infants comprise a potentially vulnerable research population that received special consideration and protections under the US Code of Federal Regulations - Subpart D. Of the four categories of research involving children, 45 CFR 46.406 is of particular interest to researchers, ethicists, parents, and clinical staff members since it concerns the conduct of research with "more than minimal risk" without the prospect of direct benefit. Parents are the surrogate decision makers for infants. When asked about this type of research in studies pertaining to older infants and children, parent themes include: concerns of medical research and research-related risk, desire to advance generalizable medical knowledge and knowledge specific to their own child's disease. There are no data on parents' perceptions regarding this category of research that target the premature, late-preterm and term newborn populations.

This study involves a questionnaire for both staff (nurses and physicians) and parents. The questionnaire represented 4 different infant scenarios in a random order. Respondents are asked to answer questions related to enrollment in a research study for each of the 4 scenarios.

Conditions

  • Infant, Premature
  • Infant, Late
  • Infant, Preterm
  • Infant

Interventions

OTHER

Survey

This was a survey

Sponsors & Collaborators

  • Christiana Care Health Services

    lead OTHER

Principal Investigators

  • Robert G. Locke, DO, MPH · Christiana Care Health Services, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-10-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02482012 on ClinicalTrials.gov