Viewing Study NCT03673566


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Study NCT ID: NCT03673566
Status: WITHDRAWN
Last Update Posted: 2020-09-24
First Post: 2018-09-10
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
Sponsor: Philips Healthcare
Organization:

Study Overview

Official Title: Clinical Evaluation of the "NICU Clinical Decision Support Dashboard"
Status: WITHDRAWN
Status Verified Date: 2020-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Business pivot caused termination of study before enrollment.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.
Detailed Description: The current NICU environment can be stressful and overwhelming for parents of babies admitted and for clinicians caring for the babies. There is a wide range of monitors in a very clinical environment that does not take into account the comfort of neonates.

The Dashboard works in parallel with EHR and systems of record, and provides a cohesive view of the patient's status and planned clinical workflow in a single location for both parents and staff. Accessories such as environmental sensors and cameras are used to ensure that the environment is comfortable and promotes optimal development of the baby. Caregivers can educate and coach parents to facilitate integrating them into their infant's care. The NICU Dashboard also supports a family view to facilitate education and assist the family in tracking core measures and developmental milestones.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: True
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: