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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02482012
Other study ID # CCC#34099
Secondary ID
Status Completed
Phase N/A
First received June 23, 2015
Last updated February 24, 2016
Start date June 2014
Est. completion date May 2015

Study information

Verified date February 2016
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date May 2015
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Survey
This was a survey

Locations

Country Name City State
United States Christiana Care Health System Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary determination of willingness to participate in research This is a survey to determine attitudes / willingness to participate in a specific category of research. 15 minutes No
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