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 A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing (NCT03729960), a na na study. The primary outcome is The Rating by the Primary Caregivers on the Use and Relevance of the Cry and Fuss Clock Generated From the LENA Recorder Data and the Rating by the Primary Caregiver on the Level of Engagement Due to the Content on the COOL Mobile App..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03729960 |
| Phase | NA |
| Condition | Healthy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Danone Asia Pacific Holdings Pte, Ltd. |
| Results posted | Yes |
2. Clinical Question
Population
The registry lists the condition as Healthy and describes a study about infant crying and fussing. Primary caregivers posted the ratings central to the primary question; healthcare professionals were asked to rate the usefulness and relevance of LENA data in general practice. Enrollment was 20 participants.
Intervention
The study evaluated a LENA recorder. The arm description says Fitbit and Cocooncam were optional. The broader study description also covers the COOL mobile app and, for exploratory measures, recording and activity-log functions associated with Cocoon Cam and the COOL app.
Comparator
This was a single-group study, with no control group or randomized comparison described. The allocation entry is NA. Consequently, the study does not provide a like-for-like treatment comparison.
Primary question
The primary question was how caregivers rated the use and relevance of the cry and fuss clock generated from LENA data, and how they rated their engagement with COOL app content. Ratings were collected over 2 weeks on a 6-point scale, with anchors of 0=Not at all and 5=Yes, very much. The meaning of scores 1 to 4 was left to the user and was not specifically defined.
3. Trial Design
This was a completed proof-of-concept study, registered as NCT03729960, with the title “A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing.” The official title identifies the Cry Management and Awareness Tool (Cool). The registry lists the study phase as NA, allocation as NA, masking as NONE, and the model as SINGLE GROUP.
The record lists enrollment of 20 and identifies a LENA group. The intervention is described as a LENA recorder, with Fitbit and Cocooncam optional. The listed start date is 2018-11-20, primary completion date is 2019-09-17, and status is COMPLETED. The sponsor is Danone Asia Pacific Holdings Pte, Ltd.
Because the design is single-group and no control group is described, the study is suited to documenting ratings and experiences in the study setting, not to estimating a randomized contrast. The absence of masking is recorded; further details about how participants or staff were informed about the study aims are not reported in the registry record. A protocol description beyond the listed study summary is not reported in the registry record.
The primary focus was caregiver ratings of LENA-derived information and app engagement. A secondary outcome concerned healthcare-professional ratings of the use and relevance of LENA data in general practice. The registry also describes exploratory measures involving crying, fussing, sleep, heart rate, device and app use, and participant and professional feedback. These aims cover several types of information, but the registry record does not supply results for them.
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
| Stage | LENA |
|---|---|
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 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 | LENA |
|---|---|---|
| Participants analysed | 20 | |
| Age, Continuous | months | 5.77 (SD 2.87) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 13 |
| Race/Ethnicity, Customized: Asian | Participants | 18 |
| Race/Ethnicity, Customized: Others | Participants | 2 |
| Region of Enrollment: Singapore | Participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as The Rating by the Primary Caregivers on the Use and Relevance of the Cry and Fuss Clock Generated From the LENA Recorder Data and the Rating by the Primary Caregiver on the Level of Engagement Due to the Content on the COOL Mobile App., measured over 2 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint concerns caregiver ratings of the use and relevance of the cry and fuss clock generated from LENA recorder data, together with ratings of caregiver engagement due to COOL mobile app content. The stated timeframe is 2 weeks. The rating scale runs from 0=Not at all to 5=Yes, very much, while scores from 1 to 4 are subjective to the user and not specifically defined.
These ratings address whether caregivers found the information and app content usable or relevant in the study context. Such feedback can be useful in a proof-of-concept study because it describes users’ reported experience, rather than establishing a clinical effect. The registry identifies the outcome unit as Participants and the parameter as a count of participants. It does not report a threshold defining which ratings would count as a positive response, nor does it provide a breakdown of ratings or participants meeting a response definition.
Without a reported distribution of the ratings, the primary endpoint cannot be interpreted as showing a particular level of usability, relevance, or engagement. The registry record also does not report a numerical primary result, an estimate of uncertainty, or an analysis method for this endpoint. Thus the outcome’s stated purpose and measurement scale can be described, but the size and precision of any observed response cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the study question and outcome measures, but it does not report the primary endpoint result. No caregiver rating distribution, count of participants meeting a response criterion, or estimate of uncertainty is listed. It is therefore not possible to characterize the observed level of relevance, usability, or engagement from the registry record.
The same distinction applies to the secondary outcome. The study planned to collect healthcare-professional ratings of the use and relevance of LENA data in general practice, but no numerical result for those ratings is reported in the registry record. The exploratory measures include crying and fussing time, perceived crying and fussing, heart rate and sleep information, app-recorded start and end times, Cocoon Cam records, usage data, and comments from caregivers and healthcare professionals. Their presence in the study description indicates areas of interest, not findings.
In general, a numerical estimate describes the observed data, while an uncertainty interval communicates how imprecisely that estimate is measured under the analysis assumptions. Neither a primary estimate nor an uncertainty interval is reported in the registry record. Statistical significance cannot be evaluated without a reported analysis and result; nor would a significance test alone describe the practical meaning of a caregiver rating.
The single-group design also limits what can be concluded. Ratings could describe the experience of participants using the devices and app, but the record does not describe a concurrent control group against which to compare those experiences. The study is not a randomized comparison, and its results, even if reported, would not by themselves separate the effect of the platform from other influences on participants’ ratings.
The enrollment of 20 is a description of study size, not evidence that the primary question was answered precisely. Precision depends on the actual outcome data and analysis, neither of which is reported for the primary outcome. The record lists zero analyses. This means that no analysis entries are reported in the registry record; it does not justify inventing an unreported result or inferring what the investigators may have analyzed elsewhere.
The serious and other adverse-event entries list zero affected participants among 20 at risk in each category, and deaths are listed as zero. These are registry counts, not a detailed account of monitoring, event definitions, or follow-up completeness. The adverse-event entries should therefore be read as the recorded figures, without extending them to a general claim about safety.
9. Statistical Methods Explained
Statistical methods in general help translate observations into estimates and describe the uncertainty around them. For this study, the registry record identifies a count of participants as the primary outcome parameter, but it does not report the observed count, a rating distribution, or a statistical analysis. No inferential method for the primary endpoint is reported in the registry record.
What does a participant count describe?
In general, a count reports how many participants meet a stated definition. Interpreting such a count requires knowing the definition, the number of participants assessed, and how missing or incomplete observations were handled. The registry describes the primary outcome as a participant count but does not state a specific response threshold or give a result. Because the scale’s intermediate values are left to users’ subjective interpretation, a clear response rule would be important for understanding any count based on ratings. Such a rule is not reported in the registry record.
How should a rating scale be understood?
In general, a rating scale records ordered responses. The endpoints of the stated scale are labeled 0=Not at all and 5=Yes, very much; the descriptions of scores 1 to 4 are not specifically defined. The values therefore communicate direction between the labeled anchors, but the registry does not establish a precise interpretation for every intermediate value. An average, a proportion meeting a threshold, and a full distribution would answer different questions. No such summary is reported for the primary outcome, so none can be inferred.
What does an uncertainty interval add?
In general, a confidence interval presents a range of values compatible with an estimate under a specified statistical model and its assumptions. It helps readers assess precision; it is not a guarantee that the true value lies within the interval. For a participant count or a proportion, the appropriate interval depends on the outcome definition, the observed data, and the method used. The registry record does not report an interval or the ingredients needed to reconstruct one. It would not be appropriate to create an interval from enrollment alone.
What is the role of hypothesis testing?
In general, a hypothesis test evaluates data against a specified null hypothesis under stated assumptions. A p-value, when reported, describes how unusual the data would be under that null and those assumptions; it does not measure the probability that a hypothesis is true or the importance of a finding. No primary analysis or p-value is reported in the registry record. The record’s planning description mentions a two-sided significance level of 0.05 for a sample-size illustration, but that planning assumption is not an observed test result and does not establish that such a test was performed.
How does the design affect interpretation?
In general, a single-group study can describe observations in the group studied, but it lacks a concurrent control contrast. Without such a contrast, changes or ratings cannot be attributed to the device or app alone. The registry identifies a SINGLE GROUP model and does not describe a randomized comparison. Masking is listed as NONE. These design entries should be considered when interpreting any reported observations; they do not substitute for results, which are not reported for the primary endpoint.
What does the planning description mean?
The registry’s sample-size description calls its figures planning illustrations computed from the observed effect, not the trial’s own design. It states assumptions of a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. It also distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. Those assumptions describe hypothetical planning calculations. They do not change the single-group design recorded for this study, and they are not evidence of observed power. The illustration values and the observed effect are not reported in the registry record.
In general, over-dispersion matters when count data vary more than a chosen statistical model expects. If a model assumes a particular amount of variation but the data are more variable, uncertainty can be understated and inference can become unreliable. Whether over-dispersion is relevant depends on the actual outcome data and model. No count-data model or assessment of over-dispersion is reported in the registry record, so it cannot be determined whether this issue arose in the analysis.
More broadly, a statistical method should match the outcome’s scale, the study design, and the data actually collected. The registry provides descriptions of planned measures but does not report the primary analysis, model, missing-data method, or estimates. General statistical concepts can clarify what those methods would be intended to do; they cannot fill in unreported methods or results for this study.
10. Multiplicity, Missing Data and Analysis Populations
The study description includes a primary caregiver outcome, a secondary healthcare-professional outcome, and several exploratory measures. These include device-recorded and parent-perceived crying and fussing, heart rate and sleep, app-entered timing, Cocoon Cam records, app usage, and feedback from caregivers and healthcare professionals. The registry lists 6 outcome measures.
When a study evaluates multiple outcomes, multiplicity is a general statistical concern: the more questions tested, the greater the chance that at least one apparently notable result arises by chance if each is considered separately. Approaches to address this can include identifying a primary outcome in advance, adjusting inference across a family of tests, or treating secondary and exploratory findings as descriptive. The registry identifies a primary outcome but does not report a multiplicity adjustment or a statistical analysis plan. Whether any adjustment was used is not reported in the registry record.
The registry lists zero analyses. No analysis populations, such as a defined set of participants included in the primary analysis, are reported. The record gives enrollment of 20, but does not say how many participants contributed data to each outcome. Missing-data definitions, reasons for missingness, imputation procedures, and sensitivity analyses are not reported in the registry record.
These omissions matter because the number of participants enrolled need not equal the number with usable data for every measure. In general, missing observations can affect both the estimate and its precision, and the direction of any effect depends on why data are missing and how they are handled. Without outcome-specific denominators and an analysis description, completeness and potential missing-data effects cannot be assessed.
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 |
|---|---|---|---|
| LENA | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| LENA | 0 of 20 |
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 |
|---|---|
| LENA | 0 of 20 |
The registry lists 20 participants at risk for serious adverse events and 0 affected. It also lists 20 at risk for other adverse events and 0 affected; deaths are listed as 0. No top serious-event terms are listed.
These entries are counts recorded in the registry. They should not be read as a detailed safety analysis: the record does not provide event definitions, a narrative of monitoring, event-specific follow-up, or information about how completely adverse events were captured. A zero count means that no affected participants are recorded in these entries; it does not establish that an event could not occur or that all possible events were observed.
The study was a single-group proof-of-concept study, not a randomized safety comparison. The adverse-event figures therefore do not provide a comparative estimate between groups. They describe what the registry reports for the LENA group and should be interpreted within that limited scope.
12. What the Result Does, and Does Not, Mean
The study was designed to investigate the use and relevance of a digital platform for infant crying and fussing. Its primary question concerned caregiver ratings of LENA-derived cry and fuss information and engagement with COOL app content. It also described healthcare-professional ratings and exploratory measures involving crying, fussing, sleep, heart rate, app activity, and feedback.
The registry record does not report the primary outcome results, the healthcare-professional ratings, or results for the exploratory measures. It therefore does not establish how participants rated the tools, how much crying or fussing was recorded, or whether any app or device measure agreed with another measure. Those findings cannot be inferred from the stated aims or from enrollment.
Even if outcome results were available, this single-group, unmasked design would support description of participants’ recorded experiences rather than a randomized estimate of comparative effectiveness. No control group is described. The record also does not report a threshold for a favorable caregiver rating, limiting interpretation of the stated participant-count endpoint.
Accordingly, the registry record documents a completed proof-of-concept study with a defined set of user-focused questions and exploratory measures. It does not report enough outcome or analysis information to judge the observed ratings, their precision, or the relation among the different measurements. The absence of reported results should not be converted into a positive or negative conclusion about the platform.
13. Why This Trial Matters Statistically
Statistically, this study is useful to consider because it brings together several kinds of measurement: caregiver and healthcare-professional ratings, device-recorded information, app-entered timings, and user feedback. These measures do not answer identical questions. A rating reflects a user’s assessment, while a recorded duration or activity measure describes a different aspect of experience. Clear outcome definitions are important when several sources of information are collected.
The primary rating scale has labeled endpoints, but the intermediate scores are explicitly subjective and not specifically defined. The endpoint is described as a count of participants, yet the registry does not report the rule by which a rating would be converted into a participant count. This makes outcome specification central to interpreting any eventual summary.
The single-group design also illustrates a distinction between feasibility-oriented description and comparative inference. A study can collect useful information about how measures are used without a randomized control contrast. But a single-group record cannot, on its own, distinguish the platform’s contribution from other factors that may shape ratings or recorded behavior.
Finally, the registry describes multiple primary, secondary, and exploratory topics but reports no analyses or outcome results. This underscores why transparent reporting of endpoint definitions, analysis populations, missing-data handling, and estimates with uncertainty is needed to assess evidence. The trial’s subject matter and measurement plan are documented; the result and its statistical precision are not reported in the registry 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 primary limitation for interpreting this study from the registry record is the absence of reported outcome results. No caregiver rating distribution, participant count meeting a response definition, estimate, or uncertainty interval is reported. The healthcare-professional and exploratory results are also not reported.
The scale description leaves scores 1 to 4 to subjective user interpretation. The registry does not state a threshold that turns these ratings into a positive-response count, despite identifying the outcome parameter as a count of participants. Without a defined response rule, the meaning of any such count would be difficult to assess.
The single-group model and absence of masking limit comparative interpretation. No control group is described, and no randomized comparison is available in the registry record. The optional use of Fitbit and Cocooncam also means the described measures may not all apply in the same way to every participant; how many participants used each optional device is not reported in the registry record.
Enrollment is listed as 20, but outcome-specific denominators and analysis populations are not reported. Missing-data handling, the analysis plan, and multiplicity procedures are also not reported in the registry record. The number of analyses listed is zero. These gaps prevent assessment of analysis completeness, precision, and the handling of the study’s several outcome topics.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing — NCT03729960.
- Registry record last updated 2020-07-08; status last verified 2020-06.
- Results first posted 2020-07-08.
- 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
NCT03729960 is a completed, single-group proof-of-concept study of a LENA recorder and the COOL digital platform for infant crying and fussing. The registry lists 20 participants, no masking, and optional Fitbit and Cocooncam use. The primary outcome concerns caregiver ratings over 2 weeks, using a 6-point scale whose endpoints are labeled and whose intermediate scores are not specifically defined.
A secondary outcome concerns healthcare-professional ratings of LENA data in general practice. The registry also describes exploratory measures of crying, fussing, sleep, heart rate, app activity, and user feedback. It lists 6 outcome measures and zero analyses. Primary, secondary, and exploratory results, analysis methods, missing-data handling, and analysis populations are not reported in the registry record.
The recorded adverse-event entries list 0 affected participants among 20 at risk for serious events, 0 among 20 at risk for other events, and 0 deaths. These are registry counts, not a comparative safety analysis.