This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Tortle Midliner and Intraventricular Hemorrhage (NCT03543046), a randomized na study. The primary outcome is Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03543046 |
| Phase | NA |
| Condition | Intraventricular Hemorrhage of Prematurity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Orlando Health, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Preterm infants enrolled in the trial. The registry record describes the clinical condition as intraventricular hemorrhage of prematurity. It does not report further eligibility details or a more specific description of the analyzed population.
Intervention
Early use of the Tortle Midliner, in addition to the NICU department’s positioning guidelines. The intended application was no later than 3 hours following birth, with continuous use through 72 hrs. of life to maintain optimal midline positioning.
Comparator
Standard care under NICU department process guidelines relevant to gestational age and provider orders. The control description mentions neutral midline head positioning with nesting and/or rolls, and bed elevation between 15° and 30°.
Primary question
Does early Tortle Midliner use affect the incidence and/or severity of intraventricular hemorrhage within the first week of life, compared with the standard-care control group? The registry record describes this as a reduction in incidence and/or severity, but does not report the outcome results or a group comparison.
The study was randomized and used a parallel-group design, which is intended to compare outcomes between concurrently assigned groups. Masking was listed as none. The stated purpose was to evaluate whether the positioning approach changed IVH outcomes in preterm infants. The record does not report whether the intervention was delivered as intended, how IVH severity categories were defined, or how outcome assessments were conducted.
3. Trial Design
This was a randomized, parallel-group trial comparing early Tortle Midliner use with a control regimen of standard NICU care. The record lists enrollment as 27 and status as terminated. The study started on 2018-08-24, and primary completion was recorded as 2020-01-09. The reason for termination is not reported in the registry record.
In the intervention arm, the Tortle Midliner was to be applied no later than 3 hours following birth under the supervision of a study investigator, alongside NICU positioning guidelines. The study purpose describes continuous use through 72 hrs. of life. The intervention description is truncated in the registry record, so additional implementation details are not reported there. The control arm followed NICU department process guidelines and provider orders; its description refers to neutral midline head positioning with nesting and/or rolls and bed elevation between 15° and 30°.
The registry record lists no masking. It does not explain whether outcome assessors were also unmasked, nor does it report the method used to generate or conceal random assignments. Those details matter when considering the possibility that knowledge of assignment could influence care, outcome assessment, or other trial procedures, but no further account is available in the record.
The planned primary outcome was the incidence and severity of IVH in preterm infants, assessed within the first week of life. The record describes planned descriptive statistics with means and proportions and comparative statistics between groups. It does not report an analysis population, a statistical model, a prespecified single contrast, or an adjustment strategy. The trial is listed as terminated, and the registry record reports no analyses. The planned comparison therefore cannot be reconstructed as an observed treatment-effect estimate from the posted results.
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: 27 subjects were randomized. 13 enrolled into the control arm and 14 in the treatment arm. 5 subjects were withdrawn after randomization ( 2 in the control arm and 3 in the treatment arm). 22 Completed study
Overall Study
| Stage | Tortle Midliner | Control Group |
|---|---|---|
| STARTED | 14 | 13 |
| COMPLETED | 11 | 11 |
| NOT COMPLETED | 3 | 2 |
Reasons for not completing this period:
| Reason | Tortle Midliner | Control Group |
|---|---|---|
| Adverse Event | 1 | 1 |
| Physician Decision | 1 | 1 |
| Protocol Violation | 1 | 0 |
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.
| Characteristic | Unit | Tortle Midliner | Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 14 | 13 | 27 | |
| Age, Categorical: <=18 years | Participants | 14 | 13 | 27 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 6 | 4 | 10 |
| Sex: Female, Male: Male | Participants | 8 | 9 | 17 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 5 | 10 |
| Race (NIH/OMB): White | Participants | 3 | 6 | 9 |
| Race (NIH/OMB): More than one race | Participants | 5 | 2 | 7 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants, measured over IVH incidence and/or severity within the first week of life.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is described as the incidence and severity of intraventricular hemorrhage in preterm infants, with assessment within the first week of life. IVH is a clinical outcome that can be expressed in terms of whether hemorrhage occurred and how severe it was. The registry description frames the study question around both incidence and severity rather than a single binary event alone.
These dimensions can be useful because an intervention might be associated with a different frequency of IVH, a different distribution of severity, or both. They are not interchangeable outcomes: a count of participants with IVH addresses occurrence, while severity categories convey additional information about the outcome among participants. The record does not report the severity categories, their definitions, or how incidence and severity were combined or prioritized for analysis.
The endpoint is relevant to the stated study question because the intervention was intended to maintain midline positioning in preterm infants, and the trial was designed to compare IVH outcomes with standard care. The endpoint description alone does not establish whether the intervention changed those outcomes. The registry record includes no primary outcome results, effect estimate, uncertainty interval, or reported comparative test. It also does not specify the timing or method of outcome ascertainment beyond the stated window of the first week of life.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of early Tortle Midliner use with standard care, but it does not report a primary outcome analysis. It lists no analyses and notes that the primary outcome has several categories or time points and was not reduced to a single comparison. Consequently, no treatment-effect estimate for IVH incidence or severity can be read from the posted results. There is no reported group-level primary outcome count, contrast, confidence interval, or p-value.
Enrollment is listed as 27. The adverse-event record gives at-risk denominators of 14 in the Tortle Midliner group and 13 in the control group. These are the denominators attached to the adverse-event entries, not a reported primary-outcome analysis. They should not be treated as evidence that every participant contributed an evaluable primary outcome, because the registry record does not report the primary analysis population or outcome completeness.
For the primary question, the absence of an estimate means that neither the direction nor the magnitude of a difference can be assessed. Precision also cannot be assessed: a confidence interval would describe the range of effect sizes compatible with the observed data under an analysis, but no such interval is reported. The record therefore does not support a conclusion about whether IVH incidence or severity differed between groups.
The study is listed as terminated. That status is relevant context, but the reason for termination is not reported in the registry record. Termination by itself does not establish whether the cause was operational, safety-related, efficacy-related, or otherwise. The record also does not report interim analyses, a stopping rule, or a statistical plan that would clarify how termination related to outcome review.
The safety entries can be described separately from the missing primary comparison. Serious adverse events affected 1 of 14 participants at risk in the Tortle Midliner group and 2 of 13 in the control group. Other adverse events affected 0 of 14 and 0 of 13, respectively. Deaths are listed as 0 in the Tortle Midliner group and 1 in the control group. These registry counts do not substitute for the IVH endpoint, and the record does not report a comparative safety analysis or attribution of events to the intervention.
Overall, the posted information documents the design and selected safety counts, but not the main comparative outcome. Descriptions of the intended intervention and endpoint explain what the trial sought to evaluate; they are not results. Any claim about the intervention’s effect on IVH would go beyond what the registry record reports.
9. Statistical Methods Explained
The registry record identifies the study as randomized, parallel, and unmasked. These design labels describe how the comparison was organized, but they do not supply the full statistical methods. The allocation method, concealment procedures, analysis model, and detailed outcome-assessment process are not reported in the registry record.
What does randomization contribute?
General statistical explanation: random assignment is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics at the start of a trial. In an individual trial, randomization does not guarantee balance, particularly when the enrollment is limited. It also does not remove the need to report who was analyzed, how outcomes were handled, or how the comparison was estimated. The record does not describe the randomization sequence or its implementation.
What does the parallel design mean?
General statistical explanation: in a parallel-group design, participants are assigned to a study arm and outcomes are compared between arms. This differs from designs where the same participant receives multiple conditions or serves as their own control. Here, the named arms are Tortle Midliner and Control Group. The record does not report the primary outcome data by arm, so the intended between-arm comparison cannot be quantified.
How should the endpoint be analyzed?
The primary endpoint is described in terms of incidence and severity, with a timeframe within the first week of life. The registry states that the planned analysis would include descriptive statistics with means and proportions, followed by comparative statistics. General statistical explanation: proportions can describe the share of participants with an event, while means summarize numeric measurements. A severity outcome may also require a comparison that respects its categories or ordering. The record does not specify the severity scale, the exact comparison, or the method selected for the endpoint.
The registry notes that the primary outcome has several categories or time points and was not reduced to one comparison. This matters because a broad outcome description does not tell readers which contrast would be treated as primary, how categories would be combined, or how multiple comparisons would be interpreted. Without the outcome results and analysis details, there is no basis for reconstructing an effect estimate or testing its statistical uncertainty.
What would an estimate and confidence interval show?
General statistical explanation: an effect estimate expresses the observed difference or other contrast between groups using a defined scale. A confidence interval conveys uncertainty around that estimate under the assumptions of the analysis. It is not a guarantee that the true effect lies within a particular interval, and its interpretation depends on the design and statistical model. The registry record reports neither an effect estimate nor a confidence interval for the primary endpoint. Statistical significance, precision, and the clinical magnitude of any difference therefore cannot be evaluated from the posted primary-outcome information.
What does the absence of an analysis mean?
The record lists no analyses. This is distinct from a reported analysis that found no difference: without outcome results and a comparison, the direction and magnitude of an effect are unknown. No p-value or other comparative statistic is reported for the primary endpoint. General statistical explanation: a p-value, when used, is a measure tied to a specified statistical model and null hypothesis; it does not measure the probability that a treatment works, nor does it describe the size or importance of an effect. No such interpretation can be applied to this record because a primary comparison is not reported.
How should planning calculations be understood?
The registry includes assumptions for planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. General statistical explanation: sample-size planning asks how many participants might be needed under specified assumptions to detect a chosen effect with a chosen operating characteristic. Such calculations are conditional on the assumed effect and method. They are not observed results and are not observed power. The registry record does not give the trial’s own sample-size justification, and no primary observed effect is reported to interpret against those planning assumptions.
More broadly, a statistically informative report would identify the analysis population, outcome definitions, missing-data handling, prespecified contrast, model, effect estimate, and uncertainty. Those elements are not reported in the registry record. As a result, the stated descriptive and comparative plan indicates the intended general approach, but it does not allow readers to reproduce or assess a primary endpoint analysis.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes incidence and/or severity of IVH, and the registry notes that the outcome has several categories or time points and was not reduced to one comparison. The record does not state which component, category, or time point was designated as the principal test, or how multiple comparisons were to be handled. A multiplicity strategy is not reported in the registry record.
General statistical explanation: when several outcomes, categories, time points, or comparisons are examined, the chance of at least one apparently unusual result can increase if each is treated as a separate test. Prespecifying a primary contrast and describing any adjustment or prioritization helps readers distinguish confirmatory analysis from exploratory comparisons. The available record does not establish whether such procedures were specified elsewhere.
Missing-data details are also not reported in the registry record. There is no reported account of the number of participants with primary outcome data, reasons for missingness, imputation, sensitivity analysis, or handling of withdrawals. The at-risk denominators in the adverse-event entries do not establish completeness of the primary outcome data.
The analysis population is not reported. The record does not say whether the primary comparison was intended to follow randomized assignment, include only participants who received the intervention, or use another population definition. It also does not describe protocol deviations or adherence. These omissions limit interpretation of both the intended analysis and the representativeness of any unreported results.
Because the registry lists no analyses and no primary outcome comparison, it is not possible to assess whether missing data or multiplicity affected a reported estimate. These are unreported analytic details, not evidence that a particular procedure was or was not used outside the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Tortle Midliner | 1 | 14 | 7.1% |
| Control Group | 2 | 13 | 15.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Tortle Midliner | 0 of 14 |
| Control Group | 1 of 13 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Tortle Midliner | 0 of 14 |
| Control Group | 0 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | Tortle Midliner | Control Group |
|---|---|---|---|
| Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | 1 of 14 | 1 of 13 |
| Hypotensive shock unresponsive to aggressive vasopressor therapy | Vascular disorders | 0 of 14 | 1 of 13 |
Serious events with the highest arm-level rate: hypotensive shock unresponsive to aggressive vasopressor therapy (7.7%), respiratory distress syndrome (7.7%).
The registry lists serious adverse events among 1 of 14 participants at risk in the Tortle Midliner group and 2 of 13 in the Control Group. Other adverse events are listed for 0 of 14 and 0 of 13, respectively. Deaths are listed as 0 in the Tortle Midliner group and 1 in the Control Group. These are descriptive entries; the registry record does not report a statistical comparison of these figures.
The record identifies “Hypotensive shock unresponsive to aggressive vasopressor therapy” and “Respiratory Distress Syndrome” as serious adverse-event terms, each listed as 7.7%. It does not specify in the posted information how these terms map to individual groups, whether events could overlap, or whether they were considered related to the intervention. The serious-event participant counts should therefore not be interpreted as a count of distinct event types or as evidence of causation.
General statistical explanation: safety counts in small trial groups can be imprecise, and an apparent difference in counts does not by itself establish a treatment-related risk difference. Interpretation depends on event definitions, follow-up, ascertainment, participant exposure, and a suitable analysis. These details are not reported in the registry record. The listed counts do not resolve the missing primary IVH comparison and do not, on their own, establish a causal safety conclusion.
12. What the Result Does, and Does Not, Mean
The trial record documents a randomized comparison intended to evaluate whether early use of the Tortle Midliner affected IVH incidence and/or severity in preterm infants. It describes the intended timing and duration of use, the standard-care control, and an endpoint timeframe within the first week of life. These details clarify the research question, but they do not show what happened to the primary outcome.
The registry does not report an IVH comparison, group-level primary outcome results, an effect estimate, a confidence interval, or a p-value. Therefore, the posted results do not establish the direction, size, or precision of any difference between groups. They also do not establish that the groups had equal outcomes. A missing estimate is not evidence of no effect; it leaves the primary question unanswered by the registry record.
The record lists serious adverse-event and death counts, but those figures are not a substitute for the primary endpoint. The event entries are descriptive and do not include a reported comparative safety analysis, event attribution, or enough detail to establish a causal relationship. The reason for the trial’s terminated status is also not reported, so that status cannot be used to infer why the study ended or what its results might have been.
General statistical explanation: trial findings are interpreted through both the estimated effect and its uncertainty, alongside the study design and outcome definitions. Neither a planned analysis nor the stated biological or clinical rationale can replace observed comparative data. Here, the design and endpoint are described, but the posted primary-outcome evidence needed to assess the intervention’s association with IVH is not reported.
The appropriate reading is consequently limited: the registry records what the trial set out to compare and provides selected adverse-event counts, but it does not provide a primary outcome result from which to draw a statistical conclusion about IVH incidence or severity.
13. Why This Trial Matters Statistically
This trial addresses a focused statistical question: whether an early positioning device, used alongside NICU positioning guidelines, is associated with a difference in IVH incidence and/or severity in preterm infants. A randomized parallel-group design is a direct framework for comparing outcomes between intervention and control arms. The registry record also makes clear that the intended endpoint spans incidence and severity, which are related but distinct ways to describe clinical outcomes.
The record is statistically important in another way: it illustrates the difference between a stated research question and an interpretable result. The study lists enrollment as 27 and gives a primary endpoint timeframe, but it does not report the primary comparison. Without outcome counts or an effect estimate and uncertainty interval, readers cannot evaluate the magnitude or precision of a difference. The absence of a reported analysis should not be mistaken for a finding of no difference.
The registry’s description of multiple categories or time points also highlights why endpoint definitions and analysis choices matter. Readers need to know what comparison was primary and how categories were treated to understand what a result would mean. Those details are not reported in the registry record.
Finally, the safety entries show why descriptive counts need careful context. The record gives serious-event and death counts, but does not report comparative analysis, attribution, or the reason for termination. Statistical interpretation depends not only on counts, but also on defined outcomes, follow-up, missingness, and a transparent analysis. The posted record therefore supports a clear account of the trial’s design and intended question, while leaving the central efficacy comparison unresolved.
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 principal limitation for statistical interpretation is that the registry record reports no primary outcome analysis. It does not provide IVH incidence or severity results by group, an effect estimate, a measure of uncertainty, or a comparative test. As a result, the primary study question cannot be answered from the posted results.
The endpoint is described broadly as incidence and/or severity within the first week of life. The record does not specify severity categories, assessment procedures, how incidence and severity were prioritized, or how multiple categories and time points were handled. It explicitly notes that the outcome was not reduced to one comparison. This prevents reconstruction of a single prespecified primary contrast.
The analysis population, primary-outcome completeness, missing-data approach, and handling of protocol deviations are not reported in the registry record. The method of randomization and allocation concealment is also not described. Masking is listed as none, but the record does not clarify whether outcome assessors were masked.
The trial is listed as terminated, but the reason is not reported. The registry record does not state whether interim analyses or stopping criteria were used. Intervention adherence and the extent of continuous use are not reported, and the Tortle Midliner arm description is truncated. These gaps limit assessment of how closely the intended intervention was implemented.
Safety interpretation is constrained by the absence of reported event attribution, comparative analysis, and fuller event-level context. The reported adverse-event counts are descriptive and cannot resolve the missing primary endpoint. These limitations describe what is unavailable in the registry record; they do not establish that particular procedures or information were absent from all trial documentation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Tortle Midliner and Intraventricular Hemorrhage — NCT03543046.
- Registry record last updated 2022-06-02; status last verified 2022-05.
- Results first posted 2022-06-02.
- 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.
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18. Record Summary
NCT03543046 is a randomized, parallel-group trial of early Tortle Midliner use compared with standard NICU care for preterm infants. The intended primary endpoint was IVH incidence and/or severity within the first week of life. The registry lists enrollment as 27, status as terminated, a start date of 2018-08-24, and primary completion on 2020-01-09.
The record describes the planned use of the device no later than 3 hours following birth and continuous use through 72 hrs. of life. It lists no masking and gives selected adverse-event counts. The reason for termination, primary outcome results, analysis population, missing-data handling, and detailed statistical methods are not reported in the registry record. No primary comparative estimate is available in the posted results.