Minor Increase Over Minimal Risk Research in NICU

NCT02482012 | Completed

• 1 other identifier: CCC#34099
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature; Infant, Late; Infant, Preterm; Infant

Keywords

research; vulnerable population; 45 CFR 46.406

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Staff

Staff nurses and physicians in the NICU

Other: Survey

Parents

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

Other: Survey

Interventions

Survey OTHER

This was a survey

Parents; Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NICU staff and parents of infants

You may qualify if:

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

You may not qualify if:

• Non-English Speaking
• Less than 18 years old

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Robert G. Locke, DO, MPH

  Christiana Care Health Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: May 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

US (1)