Minor Increase Over Minimal Risk Research in NICU

Completed

• Conditions: Infant, Late; Infant; Infant, Preterm; Infant, Premature
• Interventions: Other: Survey

• Registration Number: NCT02482012
• Lead Sponsor: Christiana Care Health Services

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-10
• Study Completion: 2015-05
• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-25
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Staff	Survey	Staff nurses and physicians in the NICU
Parents	Survey	Parents of infants in the NICU and a smaller group of parents of infants in the well baby nursery.

Primary Outcome Measures

Name	Time	Method
determination of willingness to participate in research	15 minutes	This is a survey to determine attitudes / willingness to participate in a specific category of research.

Trial Locations

Locations (1)

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States