Clinical trial NCT05762835: Neonatal Intensive Care Unit Virtual Family-Centered Rounds
Official title: Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Disorder
Neonatal Disease
Keywords: Pediatrics
Neonatal Intensive Care Units
Neonate
Clinical Trial
Telemedicine
Patient-Centered Care
Patient Reported Outcome Measures
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 486
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.


Eligibility criteria: Enrolling family units (which consists of INFANTS and PARENTS \[SURVEYS\]):

INFANT Inclusion

* Infants aged less than 365 days who are admitted to the NICU
* Have at least one adult parent or guardian with English proficiency

INFANT Exclusion

* Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information
* Infants with a previous NICU admission (and enrollment) during the trial period

PARENTS \[SURVEYS\] Inclusion

* Parents/guardians of the eligible infants (described above)
* Age 18 years and older

PARENTS \[SURVEYS\] Exclusion

* Age less than 18 years
* Non-English speaking

Primary outcomes:
measure: Parent FCR attendance
timeFrame: Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)
Secondary outcomes:
measure: Parent experience
timeFrame: Day 0 (post-NICU discharge)
measure: Family-Centered Care
timeFrame: Day 0 (post-NICU discharge)
measure: Parent Activation
timeFrame: Day 0 (post-NICU discharge)
measure: Parent health-related quality of life
timeFrame: Day 0/30/60/90 (post-NICU discharge)
measure: NICU length of stay
timeFrame: Day 0 (post-NICU discharge)
measure: Breastmilk feeding
timeFrame: Day 0/90 (post-NICU discharge)
measure: Postnatal growth failure (dichotomous)
timeFrame: Day 0 (post-NICU discharge)
measure: Postnatal growth failure (categorical)
timeFrame: Day 0 (post-NICU discharge)
Other outcomes:
measure: Neonatal growth velocity
timeFrame: Day 0 (post-NICU discharge)
measure: Adverse events and errors
timeFrame: Day 0 (post-NICU discharge)
measure: 30-day revisit
timeFrame: Day 30 (post-NICU discharge)
measure: 30-day readmission
timeFrame: Day 30 (post-NICU discharge)
measure: Temperature instability
timeFrame: Day 0 (post-NICU discharge)
measure: Central line-associated bloodstream infection
timeFrame: Day 0 (post-NICU discharge)
measure: Central line days
timeFrame: Day 0 (post-NICU discharge)
measure: Antibiotic days
timeFrame: Day 0 (post-NICU discharge)
Locations:
city: Sacramento
country: United States
facility: The Regents of the University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Jennifer L Rosenthal, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: