Minor Increase Over Minimal Risk Research in NICU

NCT ID: NCT02482012

Last Updated: 2016-02-25

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

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infant, Premature Infant, Late Infant, Preterm Infant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Staff

Staff nurses and physicians in the NICU

Survey

Intervention Type OTHER

This was a survey

Parents

Parents of infants in the NICU and a smaller group of parents of infants in the well baby nursery.

Survey

Intervention Type OTHER

This was a survey

Interventions

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Survey

This was a survey

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Parents of infants in the NICU
* Parents of infants on well-baby nursery
* NICU Staff (nurses and physicians)

Exclusion Criteria

* Non-English Speaking
* Less than 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert G. Locke, DO, MPH

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services, Inc.

Locations

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Christiana Care Health System

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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CCC#34099

Identifier Type: -

Identifier Source: org_study_id

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