Maternal Role in Oral Feed Establishment in Preterm Neonates: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Maternal Role in Oral Feed Establishment in Preterm Neonates (NCT05484726), a randomized na study. The primary outcome is Transition Time to Full Oral Feeding.

2. Clinical Question

3. Trial Design

The registry describes NCT05484726, titled “Maternal Role in Oral Feed Establishment in Preterm Neonates,” as a randomized trial with single masking and a factorial model. It lists Fatima Memorial Hospital as the sponsor and an enrollment of 130. The record does not explain the factorial structure, identify the masked party, or describe the allocation procedure beyond stating that allocation was randomized. These labels alone do not establish how treatment assignment was generated or concealed.

The intervention is perioral sensory-motor stimulation. The registry describes a maternal role progressing from observation to supervised performance and then independent performance. The intervention description also refers to sensory-motor stimulation for 5 minutes followed by a pacifier for 2 minutes. The control description says the same steps were performed by staff nurses. A further line in the intervention arm description refers to nurses performing all at T1, but the record does not explain this wording or how it relates to maternal delivery. The exact treatment contrast and timing are therefore not fully clear from the arm descriptions.

The registry gives a start date of 2022-03-01, a primary completion date of 2023-05-01, and a completed status. These dates describe the trial’s recorded timeline; they do not establish when any individual participant entered or completed follow-up. The primary outcome timeframe is described as the expected time of oral feed establishment, with assessment daily through the 14th day of perioral sensory-motor stimulation.

The primary endpoint results are reported for 49 participants in the intervention group and 48 in the control group. The record does not explain how these endpoint group counts relate to the enrollment entry, nor does it provide participant flow, exclusions, or an analysis-population definition. The phase is listed as not applicable. Further protocol details, including sample-size justification, 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.

Before assignment: Out of 142 eligible neonates, study was started with 130 as 65 in each group. Twelve neonates were excluded as 2 mothers experienced serious postnatal complications, 1 instance of parental refusal after initial participation, 1 case with incomplete data, and 8 others. Out of 65 neonates in each group, in 49 from intervention group and 48 from control group, sensory motor stimulation could be performed per protocol as 33 total neonates were excluded and details have been mentioned in table.

Overall Study

Reasons for not completing this period:

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 Transition Time to Full Oral Feeding, measured over Expected time of oral feed establishment.

The primary endpoint is transition time to full oral feeding, reported as a median in days with an inter-quartile range. The time interval begins with commencement of perioral sensory stimulation on D1 and ends when the neonate reaches the registry’s stated threshold for full oral feeding: oral intake of 120-140ml/kg/day. The registry says this was assessed daily through the 14th day of stimulation. It does not provide further detail on how the daily observations were converted into the recorded endpoint or how participants who did not reach the threshold within the stated assessment period were handled.

Time to an event can describe how long it takes for a defined milestone to occur. A median provides the central point of the observed time distribution: in general, half of observations are at or below the median and half are at or above it. An inter-quartile range describes the middle half of the observations. These summaries help convey both the typical recorded time and the spread, but they do not by themselves test whether groups differ.

The posted median is 10.0 days for the intervention group and 9.0 days for the control group. Both inter-quartile ranges are 7.0 to 13.0 days. The registry record does not report a hazard ratio, confidence interval, or statistical test for this endpoint. It also does not report censoring information or describe the handling of participants whose time to the threshold was not observed. Those omissions limit interpretation of the endpoint as a time-to-event analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry presents the primary endpoint as median time to full oral feeding, with inter-quartile range as the measure of spread. The endpoint is event-oriented: the event is reaching the stated oral-feeding threshold. In general, time-to-event methods are useful when the timing of an event matters and some participants may not experience the event during observation. Such methods can account for incomplete follow-up if the analysis and assumptions are specified. The registry does not report whether any participants had incomplete follow-up, how such observations were handled, or which time-to-event estimator or model was used.

What does a median summarize?

In general, the median is the central value of an ordered distribution. Unlike a mean, it is less affected by extreme values in the tail. It is useful when time measurements are skewed or when a typical elapsed time is more meaningful than an arithmetic average. The posted medians are 10.0 days for the intervention group and 9.0 days for the control group. The registry does not report means or the full distribution of times, so the medians should not be treated as a complete description of each group’s experience.

An inter-quartile range gives the span between the lower and upper quartiles and describes the middle half of the observations in general. Both groups have a reported range of 7.0 to 13.0 days. This measure gives some information about spread but does not show the density of observations within that span or describe the tails. It also does not measure uncertainty in a group median. A confidence interval for a median or for a between-group contrast would address uncertainty; neither is reported for this endpoint.

Why is a two-arm comparison not available?

The registry states that values are missing or not estimable for a two-arm comparison for the median-time endpoint. It reports medians and inter-quartile ranges by group, but those summaries alone are not sufficient to recover every analysis of time-to-event data. In general, a comparison may require information about event times, censoring, or the distribution of follow-up, depending on the method. The record does not provide those details or a sponsor-reported hazard ratio. No new inferential result can be derived from the posted summaries without making unsupported assumptions.

In general, a hazard ratio compares event rates over follow-up under a specified model; it is not the same quantity as a ratio of medians. A hazard ratio also depends on modeling assumptions, including whether the relative event rate is adequately represented by a single value over time. The registry’s method note says that only sponsor-reported hazard ratios are used, but no such estimate is reported in the registry record for this endpoint. Thus no hazard-ratio interpretation is available.

What can a planning illustration tell readers?

The registry’s stated planning assumptions describe illustrations based on a fraction of the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. For time-to-event tables, the stated convention is to give the total number of events; for other outcomes, it is to give participants per arm. These are design-planning assumptions, not results from the trial. Sample-size illustrations are hypothetical calculations about a future study under chosen assumptions. They are not observed power, do not show the probability that the trial’s finding is true, and do not replace a reported analysis. No numerical planning estimates are included in the record summarized by these registry entries.

In general, over-dispersion occurs when outcome variability exceeds what a statistical model assumes. If relevant to a model, accounting for it can affect standard errors and the precision of estimates. The registry does not report an over-dispersion assessment or identify a model for this endpoint; there is no basis to say that such an adjustment was used.

What does randomization contribute?

In general, random assignment aims to balance both measured and unmeasured characteristics across groups on average, reducing the risk that baseline differences explain a comparison. It does not guarantee balance in a particular trial. The registry labels this study randomized, but it does not report the sequence-generation method, concealment procedures, or baseline characteristics in the registry record for this analysis. The label should therefore be read as the recorded design classification, not as evidence that all potential sources of bias were eliminated.

The record also labels the trial single-masked and factorial. In general, masking can reduce bias in outcome assessment or care when the masked party is identified and masking is maintained. The registry does not state who was masked or how masking was implemented. A factorial design generally evaluates multiple intervention factors or combinations, but the registry does not explain the factors or their allocation. These labels cannot support further conclusions about the design’s statistical structure.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures and identifies 6 secondary outcomes. The secondary outcomes include total volume taken during each feeding, volume taken during the first 5 minutes, rate of transfer, overall transfer, proficiency, and feeding with suck-swallow-breathe coordination. The record does not state how these outcomes were prioritized for inference, whether all were analyzed, or whether any adjustment was planned for multiple comparisons. A multiplicity strategy is not reported in the registry record.

In general, testing many outcomes can increase the chance of at least one apparently notable result arising by chance. Methods for addressing multiplicity may control a family-wise error rate, control a false discovery rate, or define a hierarchy of outcomes. Which approach is appropriate depends on the study’s aims and prespecified analysis plan. No approach can be attributed to this trial from the available record.

The registry reports endpoint group sizes of 49 and 48, while the enrollment entry is 130. It does not explain the relationship between these entries. Participant flow, reasons for non-inclusion in the endpoint summaries, missing outcome data, and the analysis population are not reported in the registry record. It is therefore not possible to determine from these figures whether the primary endpoint summaries represent all randomized participants, a subset with observed outcomes, or another analysis set.

In general, missing-data handling matters because the reasons outcomes are unavailable can affect interpretation. Excluding participants with missing outcomes may introduce bias if availability is related to treatment assignment or outcome. The record does not describe missingness patterns, imputation, sensitivity analyses, or handling of incomplete time-to-event observations. It also does not report the statistical analysis plan or interim analyses. No conclusions about these practices should be inferred from the absence of detail.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists serious adverse events for 49 participants at risk in the intervention group and 48 at risk in the control group. The serious adverse event count is 0 in each group. The listed death count is also 0 in each group. These entries mean that no serious adverse events or deaths are recorded in these group summaries; they do not establish that the risk is zero.

Other adverse events are listed for 16 participants in the intervention group and 19 in the control group, with the corresponding at-risk counts of 49 and 48. The record does not provide event-level descriptions, severity categories for these other events, duration, recurrence, or an assessment of whether events were related to the intervention. It also does not report confidence intervals or a formal safety comparison. The listed counts should therefore be read as descriptive, not as evidence that one group had greater or lesser risk.

In general, an adverse-event count depends on the definitions used, the length and completeness of observation, and the procedures for collecting and classifying events. The registry does not give enough detail to evaluate these features. The absence of listed serious events in the posted summary does not rule out unrecorded events or establish equivalence between groups.

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

The registry describes a randomized comparison of maternal involvement in perioral sensory-motor stimulation with the same steps performed by staff nurses. The posted primary outcome summaries show a median transition time of 10.0 days in the intervention group and 9.0 days in the control group. Both groups have an inter-quartile range of 7.0 to 13.0 days. These figures describe the recorded distributions; they do not, by themselves, establish a causal effect or a statistically supported difference.

The registry does not report an inferential comparison for the primary endpoint, a confidence interval, a p-value, or a hazard ratio. It also does not explain how participants without an observed transition time were handled. Without these details, the precision and robustness of a between-group estimate cannot be assessed. A one-day difference between reported medians is not a substitute for a prespecified statistical comparison, and no further numerical comparison should be inferred from the posted summaries.

The registry lists zero serious adverse events and zero deaths in both groups, along with other adverse events in each group. These counts do not show that the approaches have equal safety. The definitions, observation procedures, and formal safety analysis are not reported in the registry record.

The study’s record does not provide enough detail to judge whether the observed endpoint summaries reflect the original randomized groups or a subset, how missing outcomes were handled, or how the stated factorial model was implemented. Nor does it identify the masked party or describe the analysis plan. These limits matter when interpreting both the outcome and its uncertainty.

The most defensible reading is therefore narrow: the record posts group-level median times and selected adverse-event counts for this trial, but does not provide the analysis needed to quantify the primary comparison. The results neither establish that maternal delivery changes the time to full oral feeding nor establish that the two approaches are equivalent. They also do not support medical advice or a judgment about which approach should be used.

13. Why This Trial Matters Statistically

This trial raises a statistically important question about how an intervention is delivered: maternal participation is contrasted with performance of the same stated steps by staff nurses. For such a comparison, clear definitions of the intervention, the comparator, and adherence are essential. The record describes maternal involvement stages and stimulation timing, but its arm wording is not fully clear, including a reference to nurses performing all at T1 in the intervention description. That makes it harder to identify exactly what contrast the endpoint summaries represent.

The endpoint is time to a clinically defined feeding milestone, rather than a measurement at a single fixed visit. In general, time-to-event outcomes can preserve information about when an event occurs, but their interpretation depends on follow-up, censoring, and the analysis method. The registry provides medians and inter-quartile ranges, yet does not report a hazard ratio, confidence interval, statistical test, or handling of participants who did not reach the threshold during observation. The distinction between a descriptive summary and an inferential comparison is central to reading these results responsibly.

The registry’s randomized label is relevant because randomization can support causal comparisons when assignment and follow-up are implemented and analyzed appropriately. However, the record does not describe allocation concealment, masking, baseline characteristics, or an analysis population. The factorial label is also not explained. These missing details prevent readers from assessing key design and analysis features using the registry record alone.

Finally, the registry lists multiple outcome measures without describing multiplicity control, and it provides limited safety detail. These are not merely reporting formalities: they shape how confidently readers can interpret individual findings. The trial is statistically informative as an example of why endpoint definitions, participant flow, analysis methods, and uncertainty estimates are needed alongside group summaries.

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.

Several trial-specific limitations in the registry record constrain interpretation. The primary outcome is defined by reaching an oral-feeding threshold of 120-140ml/kg/day, but the record does not explain how measurements were made, how the threshold was applied if intake varied, or how observations were handled when the threshold was not reached during daily assessment through the 14th day. It also does not report censoring or follow-up completeness.

The arm descriptions are not fully clear. The registry describes mothers progressing through observation, supervised performance, and independent performance, while another line in the intervention arm description refers to nurses performing all at T1. The record does not clarify this wording or the timing and practical distinction between the groups. The control description says the same steps were performed by staff nurses. Without additional detail on delivery, adherence, and deviations, the treatment contrast cannot be characterized precisely.

The study is labeled randomized, single-masked, and factorial, but the record does not identify the masked party, explain the factorial factors, or detail the randomization and allocation-concealment procedures. It does not report baseline characteristics, participant flow, the analysis population, or reasons the endpoint group sizes differ from the enrollment entry. These omissions make it difficult to assess selection, performance, or attrition concerns.

The registry reports descriptive primary summaries but no inferential analysis, confidence interval, p-value, or hazard ratio. It does not report a statistical analysis plan, missing-data methods, multiplicity control, or interim analyses. Safety reporting is limited to counts without event descriptions or causal assessments. These limitations apply to what can be concluded from the registry record; they do not establish that omitted procedures were or were not performed outside the record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Maternal Role in Oral Feed Establishment in Preterm Neonates — NCT05484726.
• Registry record last updated 2024-12-02; status last verified 2024-10.
• Results first posted 2024-12-02.
• 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

NCT05484726 is a completed, randomized trial sponsored by Fatima Memorial Hospital and titled “Maternal Role in Oral Feed Establishment in Preterm Neonates.” The registry lists a single-masked factorial design, enrollment of 130, a start date of 2022-03-01, and a primary completion date of 2023-05-01. The intervention is perioral sensory-motor stimulation involving mothers; the control describes staff nurses performing the same steps.

The primary outcome is median time to full oral feeding, defined as reaching oral intake of 120-140ml/kg/day. The posted median is 10.0 days in the intervention group and 9.0 days in the control group; both inter-quartile ranges are 7.0 to 13.0 days. The registry does not report an inferential comparison for this endpoint. It lists zero serious adverse events and zero deaths in each group, and other adverse events for 16 participants in the intervention group and 19 in the control group.

Details on the statistical plan, missing data, analysis population, participant flow, and the factorial structure are not reported in the registry record.