Minor Increase Over Minimal Risk Research in NICU

Infant, Premature Clinical Trial

Official title:

Minor Increase Over Minimal Risk Without Direct Patient Benefit Research in the NICU: Parental and Staff Perspectives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482012
• Other study ID #: CCC#34099
• 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

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

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