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Virtual Family-Centered Rounds for Neonatal Diseases
N/A
Recruiting
Led By Jennifer L Rosenthal, MD, MAS
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0/30/60/90 (post-nicu discharge)
Awards & highlights
Study Summary
This trial studies how virtual family-centered rounds in a neonatal unit affects parents and newborns.
Who is the study for?
This trial is for infants under one year old in the NICU with at least one English-speaking parent or guardian. It's not for babies who've been in the NICU before during the trial period, or those with child protective restrictions.Check my eligibility
What is being tested?
The study tests virtual family-centered rounds (FCR) in the neonatal intensive care unit to see how they affect both parents and their newborns' outcomes.See study design
What are the potential side effects?
Since this trial involves non-medical intervention through virtual communication methods, there are no direct medical side effects; however, technical issues or emotional impacts may be considered.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0/30/60/90 (post-nicu discharge)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0/30/60/90 (post-nicu discharge)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Parent FCR attendance
Secondary outcome measures
Breastmilk feeding
Family-Centered Care
NICU length of stay
+5 moreOther outcome measures
30-day readmission
30-day revisit
Adverse events and errors
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (Virtual Family-Centered Rounds [FCR])Experimental Treatment1 Intervention
Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR.
Group II: Control (Usual Care)Active Control1 Intervention
Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,136 Total Patients Enrolled
Jennifer L Rosenthal, MD, MASPrincipal InvestigatorUniversity of California, Davis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am the parent/guardian of an infant under 18 years old eligible for the trial.I am over 18 and the parent or guardian of an eligible infant.My baby is in the NICU and I or their guardian can speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention (Virtual Family-Centered Rounds [FCR])
- Group 2: Control (Usual Care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people forty years of age or older being accepted into the current trial?
"As per the rules of this experiment, infants aged 0 Days to 1 Year old are approved for enrollment."
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To whom is enrollment in this trial open?
"This study is looking for 447 infants between 0 Days and 365 Days old who suffer from neonatal disease. Qualified participants must meet this criteria in order to participate."
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Are there opportunities still available to enroll in this research?
"Clinicaltrials.gov confirms that the study, initially posted on March 13th 2023, is actively searching for participants. The most recent update was logged on March 21st of this year."
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What is the total size of this experiment's cohort?
"Affirmative. According to the records available on clinicaltrials.gov, this research initiative is presently recruiting volunteers; it was initially posted on March 13th 2023 and its parameters were most recently revised on March 21st 2023. A total of 447 individuals need to be recruited from a solitary medical centre for the trial's completion."
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