Pediatric DisorderNCT05762835
Neonatal Intensive Care Unit Virtual Family-Centered Rounds
A study testing Virtual family-centered rounds (FCR) in people with Pediatric Disorder and Neonatal Disease, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Disorder, Neonatal Disease
- What is being tested?
- Virtual family-centered rounds (FCR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 13 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Regents of the University of California, Davis
Sacramento, California, 95817
About this study
Official title: Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: a Cluster Randomized Controlled Trial
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.
- Conditions
- Pediatric Disorder, Neonatal Disease
- Being tested
- Virtual family-centered rounds (FCR)
- Keywords
- Pediatrics, Neonatal Intensive Care Units, Neonate, Clinical Trial, Telemedicine, Patient-Centered Care, Patient Reported Outcome Measures
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual family-centered rounds (FCR)Behavioural
Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care.
The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s).
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Virtual Family-Centered Rounds [FCR]) | Experimental | 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. Receives: Behavioral: Virtual family-centered rounds (FCR) |
| Control (Usual Care) | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent FCR Attendance
Obtained from FCR weekday observations. Defined at family unit level, accounting for possibility of multiple enrolled infants per family and variable eligible FCR encounters for each infant. We will compute the total number of possible weekday FCR encounters per family ('denominator') and the number of those for which at least 1 parent is present virtually or in-person ('numerator'). The outcome measure will be reported as a proportion (numerator/denominator). For example, if a family has 2 infants, 1 whose NICU hospitalization included 5 eligible FCR encounters and another whose NICU hospitalization includes 7 eligible FCR encounters, that family will be counted as having twelve eligible FCR encounters ('denominator'). If at least 1 parent is present for 4 of the first infant's encounters and 6 of the second infant's encounters, the family would be counted as having attended 10 ('numerator') of the 12 eligible FCR encounters. The proportion for that family unit is 0.83.
Measured: Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)
Secondary outcomes (8)
Parent Experience
Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).
Measured: Day 0 (post-NICU discharge)
Family-Centered Care
Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)
Measured: Day 0 (post-NICU discharge)
Parent Activation
Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)
Measured: Day 0 (post-NICU discharge)
Parent Health-related Quality of Life
Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)
Measured: Day 0/30/60/90 (post-NICU discharge)
NICU Length of Stay
Unit of measure: days in NICU. Obtained from electronic health record.
Measured: Day 0 (post-NICU discharge)
Breastmilk Feeding
Dichotomous outcomes. Include (a) breastmilk feeding initiation, (b) any breastmilk feeding at the time of discharge from the NICU (and 90 days later), and (c) exclusive breastmilk feeding at the time of discharge from the NICU (and 90 days later). Breastmilk feeding includes consuming milk from the birth parent via any delivery method (e.g., bottle, feeding tube, breast). Any breastmilk feeding will be defined as the infant consuming any amount of milk from the birth parent, with or without the addition of formula or fortifier. Exclusive breastmilk feeding will be defined as 100% of base feeding type as milk from the birth parent, with or without a bovine or human fortifier. Obtained from electronic health record (0 days) and parent survey (90 days).
Measured: Day 0/90 (post-NICU discharge)
Postnatal Growth Failure (Dichotomous)
Measure/Tool: Sex-specific Fenton growth charts. This dichotomous outcome will define growth failure as a weight-for-gestational-age Z-score decline of more than 0.8 standard deviations (SD) from birth to discharge. Obtained from electronic health record.
Measured: Day 0 (post-NICU discharge)
Postnatal Growth Failure (Categorical)
Measure/Tool: Sex-specific Fenton growth charts. This categorical outcome will classify the degree of growth failure as none (no decline or a decline </=0.8 SD), mild (>0.8 and </=1.2 SD), moderate (>1.2 and </=2 SD), or severe (>2 SD). Obtained from electronic health record.
Measured: Day 0 (post-NICU discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start13 Mar 2023
- Primary completion12 Apr 2024
- Study completion13 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer L Rosenthal, MD, MAS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762835
- Sponsor's protocol ID
- 1764454
- Status last verified
- Jul 2025
- First submitted
- 17 Feb 2023
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual family-centered hospital rounds in the neonatal intensive care unit: protocol for a cluster randomized controlled trial. Trials. 2023 May 16;24(1):331. doi: 10.1186/s13063-023-07340-x.
PubMed 37194089Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: Protocol for a Cluster Randomized Controlled Trial. Res Sq [Preprint]. 2023 Apr 17:rs.3.rs-2644794. doi: 10.21203/rs.3.rs-2644794/v1.
PubMed 37131689
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05762835
- Acronym / sponsor ID
- 1764454
- Conditions
- Pediatric Disorder, Neonatal Disease
- Keywords
- Pediatrics, Neonatal Intensive Care Units, Neonate, Clinical Trial, Telemedicine, Patient-Centered Care, Patient Reported Outcome Measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 13 Jul 2024 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Virtual Family-Centered Rounds [FCR]) | Experimental | Behavioral: Virtual family-centered rounds (FCR)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. |
| Control (Usual Care) | No 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual family-centered rounds (FCR)Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care. The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s). | Behavioural | Intervention (Virtual Family-Centered Rounds [FCR]) |
Primary outcome
Parent FCR Attendance
Time frame: Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)
Obtained from FCR weekday observations. Defined at family unit level, accounting for possibility of multiple enrolled infants per family and variable eligible FCR encounters for each infant. We will compute the total number of possible weekday FCR encounters per family ('denominator') and the number of those for which at least 1 parent is present virtually or in-person ('numerator'). The outcome measure will be reported as a proportion (numerator/denominator). For example, if a family has 2 infants, 1 whose NICU hospitalization included 5 eligible FCR encounters and another whose NICU hospitalization includes 7 eligible FCR encounters, that family will be counted as having twelve eligible FCR encounters ('denominator'). If at least 1 parent is present for 4 of the first infant's encounters and 6 of the second infant's encounters, the family would be counted as having attended 10 ('numerator') of the 12 eligible FCR encounters. The proportion for that family unit is 0.83.
8 secondary outcomes
Parent Experience
Time frame: Day 0 (post-NICU discharge)
Family-Centered Care
Time frame: Day 0 (post-NICU discharge)
Parent Activation
Time frame: Day 0 (post-NICU discharge)
Parent Health-related Quality of Life
Time frame: Day 0/30/60/90 (post-NICU discharge)
NICU Length of Stay
Time frame: Day 0 (post-NICU discharge)
Breastmilk Feeding
Time frame: Day 0/90 (post-NICU discharge)
Postnatal Growth Failure (Dichotomous)
Time frame: Day 0 (post-NICU discharge)
Postnatal Growth Failure (Categorical)
Time frame: Day 0 (post-NICU discharge)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37194089Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual family-centered hospital rounds in the neonatal intensive care unit: protocol for a cluster randomized controlled trial. Trials. 2023 May 16;24(1):331. doi: 10.1186/s13063-023-07340-x.
- Derived from this study: PubMed 37131689Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: Protocol for a Cluster Randomized Controlled Trial. Res Sq [Preprint]. 2023 Apr 17:rs.3.rs-2644794. doi: 10.21203/rs.3.rs-2644794/v1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Rosenthal, MD, MAS principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual family-centered rounds (FCR) in people with Pediatric Disorder and Neonatal Disease, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent FCR Attendance (time frame: Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762835, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.