Cardiac Displacement From Third Trimester to Early Childhood: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Cardiac Displacement From Third Trimester to Early Childhood (NCT02583763), a registered phase not stated study. The primary outcome is Velocity of the Cardiac Walls cm/s Divided With Chamber Length in mm = Quota cm/s / mm.

2. Clinical Question

The broader aim is to describe cardiac function in relation to IUGR, including its development over time after delivery and possible significance during early childhood. The described schedules include repeated assessments in pregnancy and after birth, although follow-up detail is not equally complete for both groups. The primary endpoint itself is a single post-delivery measure, so it addresses an early comparison rather than the full question of how cardiac function changes throughout childhood.

3. Trial Design

The study is titled Cardiac Displacement From Third Trimester to Early Childhood and is sponsored by University Hospital, Linkoeping. The registry lists a start date of 2013-01, a primary completion date of 2018-06-30, an enrollment of 61, and a status of active, not recruiting. The record does not provide a randomized allocation method. It describes the arms as IUGR fetuses and children and healthy controls, and notes that these are not a like-for-like control comparison.

For the IUGR group, cardiac movement sequences are collected during regular pregnancy ultrasound examinations. After birth, the plan is to perform echocardiography between 12 and 72 hours and again when the child is 3-4 months old. For healthy controls, cardiac movement sequences are collected on two occasions approximately 4 weeks apart during gestational weeks 28-36. The control-group description says that an echocardiogram is planned between 12 and 72 hours after birth, but the description ends without specifying any further post-delivery visit.

Echocardiography and blood sample are listed as interventions or procedures. The registry does not state whether procedures were standardized across groups beyond the described schedules, or whether outcome assessors were blinded. Allocation details, eligibility criteria, recruitment procedures, and a statistical analysis plan are not reported in the registry record. The posted information therefore supports a description of the groups and planned measurements, but not a fuller assessment of how participants were selected or how potential group differences were addressed.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Velocity of the Cardiac Walls cm/s Divided With Chamber Length in mm = Quota cm/s / mm, measured over After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age..

The primary endpoint is the velocity of the left cardiac wall at the septum divided by left ventricular length. Velocity is expressed in cm/s and length in mm, producing the stated unit cm/s/mm = quota. The record describes outlining echocardiographic images and using software to extract movement in different directions. At each timepoint, the calculation is performed three times on each image and averaged.

Ventricular length, measured from the level of the AV valve to the apex of the left ventricle, is used as a measure of heart size. The rationale in the record is that velocity increases as heart size increases. Dividing velocity by length is intended to make measurements more comparable as a child grows. This is a size-adjusted ratio, not a direct measurement of clinical status or a diagnosis.

The primary endpoint is defined at one post-delivery timepoint, between 12 and 72 hours of age. The record notes that substantial hemodynamic changes occur in all children shortly after birth and uses that broad interval to define the measurement window. The endpoint is specified as a mean of a continuous measure, with standard deviation as the stated measure of dispersion. No group means, standard deviations, or estimated group comparison are reported in the registry record, so the observed size and precision of any difference cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a numerical ratio of cardiac wall velocity to ventricular length. The registry states that the outcome is analyzed as a mean and that dispersion is described with a standard deviation. A mean gives the average value in a group; a standard deviation describes how spread out individual measurements are around that average. Neither statistic is reported for the primary endpoint in the registry record.

What does a confidence interval tell the reader?

In general, a confidence interval expresses the uncertainty around an estimated quantity, such as a group mean or a difference between groups. A narrower interval indicates greater precision under the method used; a wider interval indicates less precision. The interval is not a range containing every participant's value, and it does not remove limitations in study design or measurement. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be described from the posted information.

How should a group comparison be understood?

In general, comparing group means can estimate how far apart the groups' average measurements are. Interpretation depends on the estimate, its uncertainty, the analysis method, and the design that produced the groups. A p-value, if reported, would describe how compatible the data are with a specified statistical null model; it would not establish that a difference is clinically important or prove a causal explanation. No primary group comparison or p-value is reported in the registry record. Allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison.

Why can variability affect an analysis?

For a continuous outcome, greater variation among measurements generally makes a group mean less precise when the amount of data is held constant. The standard deviation is one way to describe that variation. Repeated image calculations, averaging, and differences in assessment timing may also be relevant to measurement quality, but the registry does not report reliability estimates or a detailed measurement-quality analysis. It describes three offline calculations per image and an averaged value, but does not give the resulting variability or explain how repeated readings are reflected in the statistical analysis.

What do the planning illustrations mean?

In general, a sample-size calculation uses assumptions about the effect to detect, variability, significance level, power, and allocation to estimate a planning requirement. The stated planning approach uses a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect expressed as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustrations are expressed as participants per arm. The record states that these are planning illustrations based on the observed effect, not the trial's own design. Such illustrations are not observed power and do not establish that the enrolled study had adequate power. No numerical planning outputs are reported in the registry record.

Observed power is not a replacement for an estimate and its confidence interval. In general, once study results are available, the estimate and its uncertainty are more informative than a calculation that uses the observed effect to describe power. The registry record does not report the primary effect estimate needed to interpret such a calculation, and it does not provide the original design assumptions or a sample-size justification.

What analysis details are absent?

The registry gives the endpoint's mean and standard deviation as its summary measures but does not report the model or test used, whether adjustment for other variables was planned, or how multiple assessments were handled. The record counts three analyses, but does not explain what those analyses are. It does not report whether an interim analysis was planned or conducted. These omissions mean that the exact inferential procedure and its assumptions cannot be assessed from the registry record.

General statistical concepts can guide interpretation, but they cannot supply the missing study estimates or analysis details. In particular, an endpoint definition is not a result, and an intended comparison is not evidence that the comparison was statistically significant or precise. The posted results needed to judge the primary endpoint are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Fetuses/Children With Fetal Growth Restriction", "Healthy Controls")
n   <- c(18, 35)
m   <- c(95, 87)
sp  <- c(18, 16)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Fetuses/Children With Fetal Growth Restriction  18  95.000  18.000  86.049  103.951
CARM  Healthy Controls  35  87.000  16.000  81.504  92.496

11. Multiplicity, Missing Data and Analysis Populations

The registry counts eight outcome measures and three analyses. Listed secondary measures include left chamber longitudinal displacement corrected for ventricular length, average longitudinal four-segment cardiac wall strain, troponin T, NT-ProBNP, IGF-1, IGFBP, and DNA methylation and gene expression in blood monocytes and lymphocytes. The registry does not report how these outcomes relate to the three analyses or which outcomes were designated for any particular analysis.

When a study assesses multiple outcomes or performs multiple comparisons, the chance of at least one apparently unusual result can increase. In general, statistical plans may address this through a prespecified hierarchy or an adjustment for multiplicity. Whether either approach was used is not reported in the registry record. The primary endpoint is identified, but the record does not state a multiplicity strategy for the secondary measures or analyses.

Missing-data handling is not reported in the registry record. There is no endpoint-specific account of participants with available measurements, incomplete follow-up, exclusions, or the method used for missing values. The overall enrollment of 61 cannot be assumed to equal the number analyzed for each outcome. Analysis populations, such as whether all enrolled participants or only participants with measured outcomes were included, are also not reported. The primary endpoint's complete-case count and any sensitivity analyses are not reported in the registry record.

12. 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 5% reporting threshold.

For the IUGR group, the record reports 0 serious adverse events among 18 participants at risk and 0 other adverse events among 18 at risk. For healthy controls, it reports 0 serious adverse events among 35 participants at risk and 0 other adverse events among 35 at risk. These counts describe the adverse-event fields in the registry; they do not establish that every possible event was assessed or captured.

The record separately reports 2 deaths in the IUGR group and 0 in healthy controls. It does not report the timing, causes, circumstances, or relationship of the deaths to study procedures or the condition under study. The adverse-event fields list no affected participants, but the separate death counts should not be treated as evidence about causation. The registry record does not explain how deaths and adverse-event reporting relate to one another.

These counts are not a comparison of safety risks: the arms are not a like-for-like control comparison, and the record does not report adjusted analyses or event details. The status is active, not recruiting, but that status alone does not explain the completeness or follow-up period of the safety information. Further details are not reported in the registry record.

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

The record describes a study intended to examine cardiac function in fetuses and children with IUGR and healthy controls, including an early post-delivery cardiac measurement. Its primary endpoint is a ratio intended to account for ventricular size when comparing cardiac wall velocity. The registry provides a rationale for using that ratio and specifies how echocardiographic images are processed.

The record does not report the primary endpoint results. No conclusion about the observed group difference, its direction, or its precision can be drawn from the registry information. The same applies to the listed secondary outcomes: their presence in the record does not mean that results or associations have been established. Numerical findings are not reported in the registry record.

Even if group estimates were available, a difference would need to be interpreted in the context of how the groups were assembled, their baseline characteristics, and missing follow-up. Allocation is not stated, and the registry warns that the groups are not a like-for-like control comparison. The study description alone therefore cannot show that IUGR caused a difference in the endpoint. General statistical significance, if available, would also not by itself establish clinical importance.

The defined primary endpoint addresses one early post-delivery measurement. It cannot by itself describe the development of cardiac function across pregnancy and childhood. The IUGR follow-up description includes a later assessment, but the control follow-up description does not specify one beyond the newborn examination. The registry does not provide enough information to determine whether equivalent longitudinal comparisons were completed.

The registry record is useful for understanding the research question, measurement, and planned groups. It is not a report of outcome findings. The actual estimates, their uncertainty, analysis details, and information about missing data are not reported in the registry record, so the results cannot be judged from this record alone.

14. Why This Trial Matters Statistically

This study raises a statistical question about measurement as well as group comparison. The primary outcome relates cardiac wall velocity to ventricular length because the record notes that velocity rises as heart size increases. The ratio is intended to support comparison as children grow. That rationale makes the endpoint's construction important: interpretation depends on what the ratio represents and on how consistently velocity and length are measured.

The time of assessment is also central. The primary measure is collected between 12 and 72 hours after birth, a period the record identifies as involving dramatic hemodynamic changes. A broad assessment window can encompass meaningful variation in timing. The registry does not report whether exact age at measurement was accounted for statistically, so its role in analysis cannot be assessed.

The study's stated interest spans pregnancy through early childhood, while the primary outcome is a single early post-delivery measurement. The described schedules also differ: later follow-up is specified for the IUGR group, but not fully specified for controls. These features matter when deciding which comparisons the data can support and whether they address the broader longitudinal aim.

Finally, the record distinguishes a planning illustration based on an observed effect from the study's own design. That distinction is statistically important: a retrospective illustration is not evidence of the trial's planned power or of the precision of an estimate. Since the primary results and uncertainty are not reported in the registry record, the central empirical question remains unresolved by the posted information.

15. 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.

Several trial-specific limitations constrain interpretation of the registry record. Allocation is not stated, and the record explicitly says the arms are not a like-for-like control comparison. It does not report the criteria used to define or recruit the groups, their baseline characteristics, or methods used to account for differences between them. The registry therefore does not support a causal interpretation of any group contrast.

The control-group follow-up description is incomplete: it states that newborn echocardiography is planned between 12 and 72 hours after delivery, then ends without specifying later assessment. By contrast, the IUGR group description includes a planned assessment at 3-4 months. The record does not clarify whether the control group had further follow-up or whether longitudinal comparisons were made at matched times.

The primary assessment spans 12 to 72 hours after birth. Although the registry gives a rationale for the selected window, it does not report whether precise measurement age was recorded, balanced across groups, or included in analysis. The record also does not report assessor blinding, reliability of image measurements, or endpoint-specific participant counts.

Statistical details are limited. The primary outcome is described as a mean with standard deviation, but the analysis method, handling of missing data, adjustment strategy, and multiplicity approach are not reported in the registry record. The primary outcome results themselves are also not reported, preventing evaluation of effect size and precision.

The registry lists deaths in the IUGR group but does not give their causes, timing, or relationship to the study. Adverse-event reporting therefore cannot be interpreted beyond the counts posted.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Cardiac Displacement From Third Trimester to Early Childhood — NCT02583763.
• Registry record last updated 2025-03-28; status last verified 2025-03.
• Results first posted 2025-03-28.
• 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.

19. Record Summary

NCT02583763 is a study of cardiac displacement and function from late pregnancy into early childhood, sponsored by University Hospital, Linkoeping. The record lists enrollment of 61, a start date of 2013-01, primary completion on 2018-06-30, and status active, not recruiting. It describes an IUGR group and healthy controls, with pregnancy and post-delivery echocardiography schedules.

The primary endpoint is left septal cardiac wall velocity divided by left ventricular length, measured by echocardiography at one point between 12 and 72 hours after birth. The stated summary is a mean with standard deviation. Secondary measures include cardiac displacement, strain, cardiac markers, growth-related biomarkers, and blood-based molecular measures.

The registry does not report primary endpoint estimates, uncertainty, detailed analysis methods, or missing-data handling. Allocation is not stated, and the record cautions that the groups are not a like-for-like control comparison. It reports 0 serious and 0 other adverse events in each group, alongside 2 deaths in the IUGR group and 0 in controls; death details are not reported in the registry record.