Neonatal Intensive Care Unit Virtual Family-Centered Rounds: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Neonatal Intensive Care Unit Virtual Family-Centered Rounds (NCT05762835), a randomized na study. The primary outcome is Parent FCR Attendance.

2. Clinical Question

The study’s stated aim is to evaluate the impact of virtual family-centered rounds on parental and neonatal outcomes. The primary endpoint is parent FCR attendance, defined as the number of eligible weekday encounters with at least one parent present divided by the number of eligible encounters. It is defined at the family-unit level, including when a family has multiple enrolled infants.

The registry also lists parent experience, family-centered care, parent activation, parent health-related quality of life, NICU length of stay, breastmilk feeding, and postnatal growth failure among the secondary outcomes. The record does not report estimates for these outcomes or results comparing the study groups.

3. Trial Design

This is a randomized, parallel-group, cluster-randomized controlled trial with no masking. The intervention is behavioral: an option for parents or guardians to take part in NICU family-centered rounds virtually. The comparison is usual care, in which parents may attend rounds in person or not attend. Parents offered virtual participation may also choose in-person attendance or nonattendance, and may use the virtual option as much or as little as they choose.

The registry lists enrollment of 514 and study status as completed. The recorded study start date is 2023-03-13, and the primary completion date is 2024-04-12. The phase is listed as not applicable. The sponsor is the University of California, Davis.

Because the trial is cluster randomized, the allocation unit is a cluster rather than necessarily an individual parent or infant. The registry record does not identify the cluster unit, the number of clusters, the allocation procedure, or whether cluster sizes differed. It also does not report the planned allocation ratio, eligibility criteria, recruitment approach, or the details of how the intervention was implemented across sites or units.

These design details matter for interpretation. Outcomes measured on individuals within the same cluster may be more alike than outcomes from different clusters. Appropriate analysis generally needs to account for the clustering, rather than treating every observation as independent. The registry record specifically cautions that a simple individual-level re-analysis would be misleading and indicates that only the sponsor’s own analysis should be shown. However, no sponsor analysis or outcome estimates are included in the posted results represented by this record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Family units enrolled and randomized. At time of enrollment, the number of infants was known, but the number of parents was unknown (because at that time did not know if family units had 1 vs. 2 parents/guardians). Enrolled 486 families (514 infants).

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Overall # baseline participants is 322 intervention families (342 infants, 242 P1s, 188 P2s = 772 total) \& 160 control families (168 infants, 119 P1s, 100 P2s = 387 total). Each family consisted of different #s of infants (e.g., twins) and different #s of parents (i.e., 1 to 2 parents/guardians per family) participants. Baseline data includes (a) enrolled infants plus (b) parents.

6. Primary Endpoint

The registry lists the primary outcome as Parent FCR Attendance, measured over Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days).

The primary endpoint is parent FCR attendance, expressed as a proportion of eligible encounters. The registry defines the numerator as eligible weekday FCR encounters at which at least one parent is present, either virtually or in person. The denominator is the total number of eligible weekday encounters for the family. The measure is calculated at the family-unit level and accounts for families with multiple enrolled infants and potentially different numbers of eligible encounters for each infant.

This endpoint describes participation across the available opportunities for rounds, rather than simply whether a parent ever attended. Expressing attendance relative to eligible encounters can reflect both the number of opportunities and the extent to which parents were present. Combining virtual and in-person attendance in the numerator means the endpoint concerns parent presence at rounds, not use of virtual technology alone. A family may be counted as attending an encounter through either mode.

The registry states that attendance is obtained from weekday observations during the NICU stay, assessed up to 396 days. It does not report the observed proportions, group estimates, confidence intervals, or the sponsor’s statistical comparison. Consequently, the endpoint definition is available, but the posted record does not show how attendance differed between groups or how precise any estimated difference was.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the trial as cluster randomized, parallel group, and unmasked. In a cluster-randomized design, groups of participants are assigned together rather than each participant necessarily being randomized independently. Participants within the same cluster may share circumstances, care processes, or other influences. As a general statistical matter, this can make their outcomes correlated. Analyses should account for that dependence so that uncertainty is not calculated as if every observation were independent.

The cluster unit, number of clusters, and statistical method used to account for clustering are not reported in the registry record. The record explicitly cautions that a simple individual-level re-analysis would be misleading and says only the sponsor’s own analysis should be shown. No sponsor analysis is reported in the posted results. Therefore, it is not possible to assess from this record whether the analysis incorporated clustering, which model was used, or how any cluster-level variation was handled.

The primary outcome is a proportion: the numerator counts eligible weekday FCR encounters attended by at least one parent, either virtually or in person, and the denominator counts eligible encounters for the family. The measure is defined at family level and allows multiple enrolled infants in a family. As a general statistical matter, proportions are bounded measures, and their precision depends on the amount of underlying information. Here, families may contribute different numbers of eligible encounters, and encounters from the same family may not be independent. The registry does not report the sponsor’s method for estimating the group proportions or their uncertainty.

A confidence interval is a range produced by a statistical procedure to express uncertainty around an estimate. In repeated use under the method’s assumptions, such intervals have a stated coverage property. The registry describes the primary outcome’s dispersion as a 95% confidence interval, but no outcome estimate or interval is reported. Therefore, there is no interval width to interpret and no way to judge the precision of the attendance result from the posted record.

Cluster correlation is one reason that nominal participant counts do not necessarily convey the effective information in a cluster trial. As a general concept, greater similarity within clusters can reduce the independent information contributed by additional participants in a cluster. The registry does not report a correlation estimate, the number or size of clusters, or details needed to quantify this issue. It would not be appropriate to infer those values or to replace the sponsor’s analysis with an individual-level calculation.

The registry includes planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as fractions of the observed effect. It describes these as planning illustrations based on the observed effect, not as the trial’s own design. Such illustrations are not observed power and do not substitute for an analysis of trial outcomes. The record does not report the trial’s sample-size justification or the numerical values for those illustrations in the registry record for this account.

The registry record does not report the statistical model, covariate adjustment, treatment of repeated measurements, handling of missing observations, or analysis population. Nor does it describe interim analyses or adjustments for multiple comparisons. These omissions prevent a detailed assessment of the sponsor’s statistical plan. They are not evidence that a particular method was or was not used; the relevant methods are simply not reported in the registry record.

Unmasking is listed as none. In general, when participants or researchers know which group is assigned, that knowledge may influence behavior, reporting, or outcome assessment, depending on the outcome and how it is measured. The registry describes the primary endpoint as obtained from weekday observations, but it does not report who conducted those observations or whether outcome assessors knew group assignment. The implications of the unmasked design therefore cannot be characterized more specifically from the record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 17 outcome measures, including parent FCR attendance as the primary outcome and a range of secondary parental and neonatal outcomes. It does not report a multiplicity strategy, such as a hierarchy of hypotheses or an adjustment to account for multiple statistical comparisons. When several outcomes are tested, the chance of at least one apparently unusual result can increase; methods for addressing this are a general statistical consideration. Because no analyses or outcome results are reported, the registry record does not permit assessment of how multiplicity was handled or whether it affected interpretation.

Missing-data methods are not reported in the registry record. The primary endpoint’s denominator depends on eligible weekday encounters, but the record does not state how unavailable observations, incomplete attendance records, or other missing information were handled. It also does not report the number of families or observations with complete endpoint data. These omissions matter because the amount and pattern of missing information can affect estimates and their uncertainty.

The analysis population is not reported. The record does not specify whether the sponsor’s analysis followed the randomized assignment regardless of participation, used a different population, or applied other inclusion rules. It also does not provide a participant flow account or analysis-specific counts. The registry’s enrollment figure alone does not show how many observations contributed to each outcome analysis.

These are reporting gaps, not findings about the conduct of the trial. The registry does not provide enough information to determine how missing data, analysis populations, or multiple outcomes were handled in the sponsor’s analysis.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event listing records zero serious adverse events among 342 participants at risk in the intervention group and zero among 168 participants at risk in the control group. It also records zero other adverse events in each group. The serious adverse event term list contains no entries. The record lists 13 deaths in the intervention group and 6 in the control group.

These are counts recorded in the registry, not estimates of comparative risk. They do not indicate causes, timing, relatedness to the intervention, or whether deaths were included in any particular analysis. The record does not provide definitions, follow-up details, or a statistical comparison for these safety entries. The at-risk counts are the group counts recorded for the adverse-event listing; they should not be treated as a substitute for outcome-specific analysis populations.

Zero reported events in a group does not establish that an event is impossible or that a risk is absent. With no reported analysis or uncertainty estimate, these entries alone do not support a conclusion about comparative safety. The death counts should likewise be read as registry-recorded counts without inferring cause or treatment relationship.

12. What the Result Does, and Does Not, Mean

The trial addresses a practical question: whether offering parents a virtual way to join NICU family-centered rounds is associated with parent attendance and other parental or neonatal outcomes, compared with usual care. Its primary endpoint is defined in a way that counts either virtual or in-person presence at eligible weekday encounters. That definition focuses on whether a parent attends, rather than on virtual attendance alone.

The registry record does not report the primary outcome estimates or the sponsor’s analysis. It therefore does not establish whether attendance was higher, lower, or similar between groups, nor how precisely any difference was estimated. The same limitation applies to the listed secondary outcomes. Trial completion and enrollment are details about the study record, not outcome findings.

The design is cluster randomized, so appropriate interpretation depends on analysis that accounts for the clustering. The record cautions against individual-level re-analysis, while not reporting the sponsor’s methods or estimates. A result from a cluster-aware analysis could not be reconstructed from the information recorded.

The intervention is an option, not mandatory virtual participation. Parents in the intervention group could participate virtually, attend in person, or not attend, and could choose how much to participate. Any outcome would need to be understood in light of that choice structure and the endpoint’s combined measure of in-person and virtual attendance. The record does not report how often each mode was used.

Accordingly, the posted information supports describing the study question, design, endpoint definition, and recorded safety counts. It does not support a claim that the virtual option changed attendance, parental experience, or neonatal outcomes. It also does not support a conclusion that there was no effect. The direction and magnitude of any outcome differences remain unreported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically notable because its randomized design is cluster based, while its primary outcome is defined for families and their eligible encounters. Those features make the unit of assignment, unit of measurement, and unit of analysis important. A sound interpretation must account for the possibility that observations from the same cluster or family are related. Treating every encounter or participant as independent could give an inappropriate impression of precision.

The endpoint also illustrates the distinction between an intervention’s availability and its uptake. Virtual FCR is offered as an option, while parents retain the choice to attend in person or not attend. The primary measure counts presence through either mode. It therefore addresses family attendance at rounds, not simply whether the virtual feature was used. These are different statistical questions and would require appropriately defined outcomes.

The record identifies several secondary domains, spanning parent-reported experiences and health-related measures as well as neonatal outcomes. Reporting estimates and their uncertainty across those outcomes would be important to understand the breadth of the findings and the role of multiple comparisons. Those analyses are not reported in the registry record.

The central statistical lesson is that a completed randomized study and a clearly described endpoint do not, by themselves, provide evidence about the size or precision of an effect. Here the registry record gives useful design and measurement details, and it explicitly warns against a simple individual-level re-analysis. However, it does not include the sponsor’s outcome analysis. Without that analysis, neither the primary attendance question nor the listed secondary questions can be answered from the posted results.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Important trial-specific details are absent from the registry record. It does not identify the cluster unit or number of clusters, describe the allocation procedure, or state the planned allocation ratio. Those details are relevant to understanding the randomization and the information available for a cluster-aware comparison. The record’s caution against individual-level re-analysis underscores that the design cannot be assessed as if it were ordinary individual randomization.

The primary outcome depends on observed eligible weekday encounters, with families potentially contributing different numbers of encounters and, in some cases, multiple infants. The record defines the numerator and denominator but does not report the observed data, rules for unavailable observations, or how unequal numbers of encounters were treated analytically. It also does not report whether or how the observations were adjusted for clustering at family level.

The intervention allows parents to choose virtual attendance, in-person attendance, or nonattendance. The registry does not report uptake of virtual participation or adherence to the offered option. Because the primary endpoint combines virtual and in-person attendance, it would not on its own distinguish changes in total attendance from changes in attendance mode.

Outcome estimates, confidence intervals, and the sponsor’s analyses are not reported. The registry also does not describe missing-data handling, analysis populations, multiplicity procedures, or the statistical model. These gaps prevent assessment of the precision, robustness, and completeness of any comparative result. The safety listing lacks event definitions, causes, timing, and comparative analyses. These limitations concern what can be interpreted from the registry record; they do not establish that the unreported methods or results were absent from other study materials.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Neonatal Intensive Care Unit Virtual Family-Centered Rounds — NCT05762835.
• Registry record last updated 2025-08-17; status last verified 2025-07.
• Results first posted 2025-08-17.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes NCT05762835, “Neonatal Intensive Care Unit Virtual Family-Centered Rounds,” as a completed, randomized, parallel, cluster-randomized controlled trial with no masking. The sponsor is the University of California, Davis. Enrollment is listed as 514; the recorded start date is 2023-03-13 and the primary completion date is 2024-04-12.

The intervention offers parents or guardians an option to participate in NICU family-centered rounds virtually, alongside the option of in-person attendance or nonattendance. The primary endpoint is the family-level proportion of eligible weekday encounters attended by at least one parent, virtually or in person, during the NICU stay, assessed up to 396 days.

Secondary outcomes cover parent experience and health-related measures, NICU length of stay, breastmilk feeding, and postnatal growth failure. The registry lists 17 outcome measures and zero analyses. Numerical outcome results and the sponsor’s analysis are not reported in the registry record. The adverse-event listing records zero serious and zero other adverse events in both groups, with 13 deaths in the intervention group and 6 in the control group.