Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes (NCT02901665), a non-randomized na study. The primary outcome is Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU).

2. Clinical Question

3. Trial Design

This was a completed pilot study with a non-randomized, parallel pre/post design. The intervention was introduced across the NICU, and outcomes before implementation were compared with outcomes afterward. The pre-intervention arm had no intervention; the post-intervention arm followed unit-wide implementation of the expectation that families spend 4 hours per day in the NICU with their infants. Before implementation, families were encouraged to come as much as they could.

The registry lists enrollment of 191 and records the study as completed. The study start date is 2014-09-01, and primary completion is recorded as 2018-09-30. The listed phase is NA. The sponsor is Ann & Robert H Lurie Children's Hospital of Chicago. These registry entries describe the study record, but they do not establish how participants were recruited, how many contributed data to each outcome, or whether all participants had measurements at both time points. Those details are not reported in the registry record.

Because allocation was not randomized, the pre- and post-intervention groups may differ for reasons other than the intervention. A change over time could also reflect other changes in clinical practice, staffing, patient mix, or unit conditions. Whether such factors were measured or adjusted for is not reported in the registry record. Masking is recorded as none. In a unit-wide communication intervention, families and staff would know which period they were in, so expectations or changes in behavior could be related to awareness of the intervention.

The study lists the Parent Stressor Scale: Neonatal Intensive Care Unit as the primary outcome. Secondary outcomes include length of stay in days, parent kangaroo care rate, and mothers breastfeeding rate. The registry lists 7 outcome measures and 7 analyses, but details for all measures and the statistical methods used for their analyses are not reported in the registry 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Enrolled mothers and fathers

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: Pre-FCC intervention analyzed 40 infants, 40 mothers and 20 fathers (or 60 total parents) Post-FCC intervention analyzed 38 infants, 38 infants and 15 fathers (or 53 total parents)

6. Primary Endpoint

The registry lists the primary outcome as Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU), measured over Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days..

The primary endpoint is the Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU), a measure of stress experienced by enrolled mothers and fathers in relation to their infant’s NICU care. The registry describes assessment at baseline, at NICU admission, and again at NICU discharge. The baseline timing is stated as admission at birth, from birth to 2 weeks of infant age; discharge measurement occurred at an average of 47 days.

The measure uses a 5 level Likert scale, with responses from not experienced (0) to extremely stressful (4). Higher scores indicate more stress experienced. The total score is calculated using the average of subscale scores, and the total score also ranges from 0-4 units on the scale. The registry specifies a mean as the summary measure and standard deviation as the measure of dispersion.

Using a validated instrument gives the study a structured way to assess parent-reported stress rather than relying on an informal impression. Measuring at admission and discharge also allows the intended assessment to cover different points in the NICU stay. However, the registry record does not report the observed means or standard deviations for either group, the number of parents with measurements at each time point, or the method used to handle paired measurements. It therefore does not show the size or precision of the primary outcome contrast.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a continuous primary outcome summarized as a mean with standard deviation. It does not describe the statistical tests, regression models, covariate adjustments, or other analysis procedures used for the primary endpoint. The explanations below are general statistical context, not a description of methods confirmed for this study.

What does a mean and standard deviation describe?

In general, a mean summarizes the average score in a group. A standard deviation describes how spread out individual scores are around that average. Reporting both can help readers distinguish a group’s typical score from the variability among people in that group. For the PSS: NICU, the scale runs from 0-4 units, with higher scores indicating more stress. But the registry record does not report either group’s mean or standard deviation, so no numerical comparison can be interpreted.

What would a group contrast mean?

In general, a group contrast would quantify how scores in the post-intervention period compare with scores in the pre-intervention period. An estimate alone would not show its precision. A confidence interval communicates the uncertainty around an estimate under the chosen model and assumptions. A narrow interval generally indicates more precision than a wide interval, though both the estimate and the interval need substantive interpretation. No primary contrast or confidence interval is reported in the registry record.

Why does the pre/post design matter?

Random allocation, when used, can help balance measured and unmeasured characteristics between groups on average. This study is recorded as NON-RANDOMIZED, and the comparison is between periods before and after a unit-wide change. The groups may therefore differ in participant characteristics, clinical context, or other conditions that changed over time. A statistical adjustment can address measured differences under appropriate assumptions, but it cannot automatically remove bias from unmeasured factors. Whether any adjustment was performed is not reported in the registry record.

In general, a before-and-after contrast can reflect both the intervention and changes that happen alongside it. A contemporaneous comparison group can sometimes help distinguish intervention-related change from broader time trends, but no such design is described in this record. The registry also does not report repeated time periods, a model for time trends, or checks of baseline comparability. These omissions prevent readers from assessing how the analysis may have separated the intervention period from other changes.

Why might the timing of measurements matter?

The primary outcome is described as measured at baseline and at NICU discharge. In general, if the same parent contributes scores at both times, those observations are related rather than independent. An analysis should account for that dependence when estimating change. It may also need to address participants who have a measurement at one time but not the other. The registry does not report whether the same parents provided both assessments, how the observations were linked, or how missing measurements were handled. Therefore, no particular paired or repeated-measures method can be attributed to the study.

The registry describes the discharge measurement as occurring at an average of 47 days. In general, variation in length of stay can mean that participants are assessed after different durations in the NICU. That timing may matter when interpreting discharge stress scores or change from admission. Whether the analysis accounted for timing or length of stay is not reported in the registry record.

What does over-dispersion mean in general?

Over-dispersion is a general concern for count or rate outcomes when observed variability is greater than a statistical model expects. If a model assumes less variability than the data contain, uncertainty can be understated and inference can be too optimistic. This concept may be relevant to some rate or count outcomes, depending on how they were measured and analyzed. The registry record does not describe the data distributions or models for the secondary outcomes, so it is not possible to say whether over-dispersion arose or how it was handled in this study.

How should planning illustrations be read?

The record describes a sample-size planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect, and that non-time-to-event illustrations are expressed as participants per arm for 80% power or another stated power level. These are planning illustrations, not observed trial results and not observed power. The numerical planning scenarios are not reported in the registry record. The record also does not state that these assumptions were the trial’s original design or analysis plan.

A planning calculation is conditional on its assumptions. In general, it describes the sample size that a hypothetical study might require under specified conditions; it does not establish that a completed study had adequate precision, nor does it change the uncertainty in observed estimates. Because the registry does not report the primary effect estimate or the numerical planning outputs, neither can be assessed.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 outcome measures and 7 analyses. It identifies the PSS: NICU as the primary outcome and lists length of stay in days, parent kangaroo care rate, and mothers breastfeeding rate as secondary outcomes. The titles or results for all remaining measures are not reported in the registry record. The record does not describe a multiplicity strategy, such as adjusting inference across several outcomes or identifying a prespecified testing hierarchy. Without that information and the actual test results, the chance of false-positive findings across multiple analyses cannot be assessed.

Missing data are also an important consideration because the primary outcome is described at baseline and discharge. The record does not report how many participants had scores at each time, whether some parents lacked a follow-up score, the reasons for missingness, or the approach to incomplete observations. It does not state whether the analysis used complete cases, imputation, or another method. These details matter because an analysis based only on participants with complete measurements may be biased if missingness is related to stress or other relevant characteristics.

The record describes the primary outcome population as enrolled mothers and fathers, but does not specify the analysis population or how participants were included in each outcome analysis. It also does not report whether analyses were conducted according to any prespecified population definition. The registry’s enrollment of 191 should not be taken to mean that every enrolled person contributed to every analysis. These analysis and missing-data details are not reported in the registry record, limiting assessment of representativeness and robustness.

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 safety entries report zero serious adverse events and zero other adverse events in the pre-FCC Intervention group, with 100 at risk. They report zero serious adverse events and zero other adverse events in the post-FCC Intervention group, with 91 at risk. Deaths are recorded as 0 in each group. No serious adverse event terms are listed.

These figures should be read as the adverse-event counts and denominators recorded in the registry, not as a comparison showing that the groups had identical safety experience. A zero recorded count does not demonstrate that an event was impossible, that every event was captured, or that the intervention had no safety implications. The record does not describe how adverse events were collected, the observation period for safety reporting, or the completeness of reporting. It also does not report a statistical comparison of the safety entries. The groups are defined by pre- and post-intervention periods rather than random assignment, so differences in the recorded populations or observation conditions could affect comparisons.

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

This study addresses a practical unit-level question: what outcomes were observed before and after communicating a minimum expectation for parent presence in the NICU? Its design places the intervention in routine care and assesses outcomes across periods. That can be useful for describing implementation in a clinical setting. The record establishes the intervention’s intended message and identifies parent stress as the primary endpoint, with additional outcomes related to infant care and unit experience.

The record does not provide the primary outcome estimates or the results for the listed secondary outcomes. It therefore does not establish whether scores or other outcomes changed, how large any change was, or how precisely it was estimated. The intervention description also does not demonstrate how much time parents actually spent in the NICU after the expectation was communicated. An intended policy or message and actual exposure are not interchangeable.

Even if numerical differences were available, the non-randomized pre/post design would require caution about causal interpretation. Outcomes that differ between periods may reflect the intervention, other contemporaneous changes, or differences in the families and clinical circumstances represented in each period. Statistical adjustment can be helpful for measured factors but does not by itself establish causation. The registry record does not report enough analysis detail to evaluate those issues in this study.

The posted safety counts provide a limited description of recorded adverse events and deaths in the two periods. They do not answer the primary stress question or prove the absence of unrecorded events. More broadly, the absence of reported primary estimates is not evidence that there was no change; it means the size, direction, and precision of a change cannot be determined from the registry record.

The appropriate interpretation is therefore descriptive and bounded: the registry documents a completed non-randomized pilot study and its planned unit-wide communication intervention, but does not report the primary comparative results needed to judge the stress outcome. No treatment recommendation or conclusion about benefit follows from the information in the record.

13. Why This Trial Matters Statistically

This study is statistically interesting because it evaluates an organizational change implemented across a NICU rather than a treatment assigned to individual participants at random. Such interventions are often assessed in the setting where they are intended to operate, but that setting can make causal attribution difficult. The pre/post structure makes the timing of implementation central to interpretation: changes after implementation may coincide with other changes in the unit or its patient population.

The primary endpoint also illustrates the value of defining a measure clearly. The record states what the PSS: NICU measures, how the response scale is oriented, when it is assessed, and how the total score is constructed. Those details help readers understand what a mean score would represent. But clear endpoint definitions do not substitute for reporting the actual group summaries and comparative estimate. Without those, neither the magnitude nor the precision of the primary outcome can be judged.

The design also raises analysis questions that are important beyond this particular study. When an outcome is assessed at admission and discharge, the relationship between repeated observations, incomplete follow-up, and differences in time to discharge can all affect estimates. The registry does not report how these issues were handled. Naming these uncertainties helps readers distinguish a documented outcome definition from a fully documented analysis.

Finally, the record separates the intervention’s intended message from direct evidence of exposure. An expectation of 4 hours per day does not itself tell readers whether families were present for that duration. Measures of implementation and actual parent presence would help explain whether the intervention was delivered and how it related to outcomes. Such measurements are not reported in the registry record. The study thus highlights how design, implementation measurement, outcome reporting, and uncertainty all shape the conclusions that can be drawn from a clinical trial record.

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.

The most consequential limitation for interpretation is that the registry record does not report the primary outcome results. Without group means, standard deviations, an estimated contrast, or an interval expressing uncertainty, readers cannot determine the observed pattern in parent stress. Results for the secondary outcomes are also not reported in the record.

The non-randomized pre/post design leaves the comparison open to differences between periods. Other unit changes, shifts in participant characteristics, or secular trends could be associated with outcomes. The record does not report whether these factors were measured, whether baseline characteristics were compared, or whether adjusted analyses were used. Masking is recorded as none, and the unit-wide intervention involved communicating a new expectation, so awareness of period assignment could also influence reported outcomes or behaviors.

The record does not describe actual adherence to the expectation of 4 hours per day, variation in parent presence, or how intervention implementation was monitored. It therefore cannot show the degree to which the intended change occurred. The primary outcome was assessed at admission and discharge, but details on repeated measurements, missing observations, analysis populations, and handling of incomplete data are not reported. The average of 47 days to discharge also does not describe the range of assessment times or whether timing was incorporated into analysis.

The registry lists 7 outcome measures and 7 analyses but does not report a multiplicity plan or all outcome details. The methods used to estimate contrasts and uncertainty, including any adjustment for covariates, are not reported. Finally, the adverse-event entries contain zero counts, but the registry does not describe collection procedures or completeness. These limitations restrict conclusions about causal effects, precision, the robustness of analyses, and the completeness of safety reporting.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes — NCT02901665.
• Registry record last updated 2026-05-29; status last verified 2026-05.
• Results first posted 2026-05-29.
• 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

NCT02901665 is a completed, non-randomized, parallel pre/post pilot study titled “Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes.” The intervention communicated an expectation that parents spend 4 hours per day in the NICU, compared with the previous message to come as much as they could. Enrollment is listed as 191; the study start date is 2014-09-01, and primary completion is 2018-09-30.

The primary outcome was the Parent Stressor Scale: Neonatal Intensive Care Unit, measured at admission and discharge among enrolled mothers and fathers. The record lists secondary outcomes of length of stay, parent kangaroo care rate, and mothers breastfeeding rate. It does not report primary comparative estimates, uncertainty measures, detailed statistical methods, missing-data procedures, or results for the secondary outcomes. Adverse-event entries record zero serious events, zero other events, and zero deaths in each period’s listed safety population.