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 Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain (NCT03396588), a randomized phase 3 study. The primary outcome is Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03396588 |
| Phase | Phase 3 |
| Condition | Neonatal Abstinence Syndrome |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 120 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Henrietta Bada |
| Results posted | Yes |
2. Clinical Question
Population
Neonates with neonatal abstinence syndrome (NAS) were the population of interest. The registry record describes the trial as evaluating treatment for neonates with NAS and reports enrollment of 120 participants. It does not provide further eligibility criteria or a detailed description of the enrolled participants in the record.
Intervention
One randomized group received clonidine. The arm description specifies 1mcg/kg/dose, with a dosing interval of 3 or 4 hours. The registry record does not provide additional treatment-duration details in the information.
Comparator
The comparison group received morphine at 0.06 mg/kg/dose, with a dosing interval of 3 or 4 hours. The record describes both clonidine and morphine as drug interventions and the allocation as randomized.
Primary question
The primary outcome concerns change in mean neurobehavioral performance summary scores on the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS). Scores were to be assessed at baseline, 5-10 days post natal age, and again at one-month post-natal age, between 4-6 weeks of age, or at discharge, whichever came first. The registry record does not report comparative results for these changes, so it does not establish which arm had higher or lower scores.
The study’s stated objective was to evaluate clonidine as a treatment for neonates with NAS, and its brief summary describes a broader interest in pharmacological treatment and longer-term developmental outcomes. The recorded primary endpoint is an early neurobehavioral measure, rather than a direct report of a later developmental outcome. Secondary outcomes listed in the registry are Duration of Treatment and Childhood Behavior Checklist 1.5-5 T-Scores. Their inclusion does not substitute for the missing primary outcome comparison or establish a result for either secondary outcome.
3. Trial Design
The registry classifies NCT03396588 as a phase 3, randomized, quadruple-masked, parallel-group trial. It records enrollment of 120 and a completed status. The study concerns neonatal abstinence syndrome and compares two drug interventions: clonidine and morphine. The listed sponsor is Henrietta Bada. The record lists the study start as 2017-12-07 and primary completion as 2024-04-10.
In a parallel-group design, participants are assigned to one treatment group and remain in that group for the trial’s relevant comparisons; this differs from a design in which the same participant receives each intervention in sequence. Random allocation is intended, in general, to reduce systematic differences between groups at assignment. Masking is intended, in general, to limit the influence of knowledge about assignment on aspects of trial conduct or outcome assessment. The registry’s labels do not identify which roles were masked, how masking was maintained, or whether it was successfully maintained. Those details are not reported in the registry record.
The clonidine arm description specifies 1mcg/kg/dose at a dosing interval of 3 or 4 hours, while the morphine arm description specifies 0.06 mg/kg/dose at a dosing interval of 3 or 4 hours. The listed descriptions do not explain how the interval was selected, whether dosing changed over time, or how treatment was stopped. Further protocol details of that kind are not reported in the registry record.
The primary outcome is a set of NNNS summary scores measured at baseline and at a later assessment. The follow-up is described as one-month post-natal age, between 4-6 weeks of age, or at discharge, whichever came first. Thus, the specified endpoint includes multiple neurobehavioral domains and the later assessment can occur at different points according to the stated timing rule. The record identifies secondary outcomes but does not include their comparative results in the information. It also does not report a statistical analysis plan, planned interim analyses, or a sample-size justification. The registry’s completion status describes study status; it does not itself provide evidence about the outcome of the comparison.
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 | Clonidine | Morphine |
|---|---|---|
| STARTED | 60 | 60 |
| COMPLETED | 58 | 57 |
| NOT COMPLETED | 2 | 3 |
Reasons for not completing this period:
| Reason | Clonidine | Morphine |
|---|---|---|
| Physician Decision | 2 | 3 |
Analysis population for the primary outcome, as defined in the registry: Some babies were unable to be assessed in certain domains and therefore were not included in the total analyzed for that domain.
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 | Clonidine | Morphine | Total |
|---|---|---|---|---|
| Participants analysed | 60 | 60 | 120 | |
| Age, Categorical: <=18 years | Participants | 60 | 60 | 120 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | weeks | 38.7 (SD 1.2) | 38.3 (SD 1.3) | 38.4 (SD 1.2) |
| Sex: Female, Male: Female | Participants | 23 | 30 | 53 |
| Sex: Female, Male: Male | Participants | 37 | 30 | 67 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 4 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 60 | 56 | 116 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 53 | 52 | 105 |
| Race (NIH/OMB): More than one race | Participants | 6 | 8 | 14 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 60 | 60 | 120 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS), measured over Baseline (5-10 days post natal age) and one-month post-natal age (between 4-6 weeks of age), or at discharge, whichever comes first..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in mean summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS). The scale covers multiple aspects of infant neurobehavior, including habituation, regulation, attention, quality of movement, reflexes, arousal, muscle tone, excitability, lethargy, and stress/abstinence. The registry describes a separate score range for each domain and states that a higher score for an item indicates a higher level of the construct measured by that item. For example, a higher hypertonicity score means greater hypertonicity; a higher hypotonicity score means greater hypotonicity.
Using a structured neurobehavioral assessment can characterize several dimensions of infant behavior, rather than reducing the assessment to a single general impression. The registry says no cutoff score has been published for normal or abnormal behavioral performance. Consequently, a score should be read as a measure of its named construct, not as a diagnosis or as an automatic classification of normality or abnormality. Different domains also have different ranges, so their score magnitudes should not be treated as directly interchangeable.
The recorded assessment schedule includes baseline at 5-10 days post natal age and a later assessment at one-month post-natal age, between 4-6 weeks of age, or at discharge, whichever came first. The endpoint is described as mean change, with a 95% Confidence Interval as the dispersion measure. The comparative mean changes and their confidence intervals are not reported in the registry record. Some babies were unable to be assessed in certain domains and were therefore not included in the total analyzed for that domain. The number assessed in each domain is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its measurement schedule but does not report the outcome values. In particular, it does not give mean NNNS scores at either assessment, mean changes by arm, a between-arm estimate, or a confidence interval for a comparison. It therefore does not show the direction or size of any difference between clonidine and morphine on the primary outcome. No p-value or other result from a primary-outcome comparison is reported in the registry record.
This distinction matters because a study’s objective, design, and endpoint do not constitute its findings. The brief summary states that the objective was to evaluate clonidine and expresses a central hypothesis about treating withdrawal manifestations. A hypothesis is a statement to be tested, not a result. The completed status and enrollment figure likewise do not reveal whether the observed scores favored either arm, whether the groups were similar, or how uncertain an estimate might be.
In general, a mean summarizes the average score for the participants included in a particular analysis. A confidence interval conveys uncertainty around an estimate under the assumptions of the statistical method used. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. Those general interpretations cannot be applied to a specific treatment comparison without the estimate and interval. Although the registry identifies 95% Confidence Interval as the dispersion measure for the primary outcome, the actual intervals are not reported in the registry record.
The primary measure consists of multiple domains, each with its own interpretation and score range. The record states that a higher score corresponds to a higher level of the relevant construct, but that does not make higher scores universally better or worse: the meaning depends on the domain. For example, more hypertonicity and more hypotonicity describe different constructs. The record also states that no cutoff score is published for normal or abnormal behavioral performance. A score difference, if reported, would therefore need to be interpreted in the context of the specific domain and should not be converted into a normal/abnormal classification using a threshold that the record does not provide.
Follow-up was planned at baseline and at one-month post-natal age, between 4-6 weeks of age, or at discharge, whichever came first. The endpoint thus concerns an early assessment rather than a reported long-term developmental result. Childhood Behavior Checklist 1.5-5 T-Scores is listed as a secondary outcome, but its results are not reported in the registry information. Duration of Treatment is also listed without comparative results. No conclusion about these secondary outcomes can be drawn from their names alone.
Safety information is reported separately from the primary neurobehavioral endpoint. The record reports serious adverse events, other adverse events, and deaths by arm, but those counts do not replace the missing primary outcome analysis. Nor do the counts alone establish the cause of an event or permit a complete assessment of comparative safety. The registry record does not report enough detail to connect any particular safety event to an individual participant’s NNNS score or to infer a causal pathway.
The defensible statistical interpretation is therefore limited: the registry describes a randomized comparison and specifies what the primary endpoint was intended to measure, but does not report the primary comparative result. Any statement that one intervention produced better, worse, or equivalent neurobehavioral performance would go beyond the results reported in the registry record.
9. Statistical Methods Explained
The registry describes the trial as randomized, parallel-group, and quadruple-masked. These design terms describe how a trial is organized, not the numerical result of its treatment comparison. Random allocation is intended, in general, to make treatment groups comparable at the point of assignment with respect to measured and unmeasured characteristics, apart from chance variation. A parallel-group structure assigns participants to one intervention group for the comparison. Masking can, in general, reduce the influence of treatment knowledge on care, measurement, or interpretation. The registry does not state which people were masked, how assignment was concealed, or how masking was maintained; those implementation details are not reported in the registry record.
The primary outcome is continuous: the registry identifies it as a mean of a continuous measure. A continuous outcome can take a range of values, rather than being limited to a category such as event/no event. The endpoint is not one overall NNNS score in the description. It consists of summary scores from several domains, each measuring a different aspect of infant neurobehavior. The stated direction is domain-specific in meaning: higher scores indicate more of the named construct. Because the constructs differ, the score ranges differ, and the record gives no normal/abnormal cutoff, comparisons need to stay attached to the domain being measured.
The endpoint description specifies measurements at baseline and follow-up. In general, change compares a participant’s or group’s later measurement with its baseline measurement. A comparison of mean changes between arms would address whether the average change differed between groups, while a comparison of scores at follow-up could address a related but not identical question. The registry record does not report which model or exact calculation was used for the primary analysis, nor does it provide the arm-specific means, changes, or between-arm estimate. That analysis method is not reported in the registry record.
The record names a 95% Confidence Interval as the dispersion measure. In general, a confidence interval gives a range of values compatible with an estimate under the analysis assumptions and conveys the estimate’s precision. It is not a guarantee that the true value lies in the reported interval, and it does not by itself establish clinical importance. For a treatment comparison, the interval’s location relative to the null value and its width are relevant to statistical interpretation. Here, no primary comparison interval or estimate is reported, so neither its precision nor its compatibility with different effects can be assessed from the registry record.
The primary assessment occurs at baseline, 5-10 days post natal age, and at one-month post-natal age, between 4-6 weeks of age, or at discharge, whichever came first. In general, differing follow-up timing can affect interpretation if measurements are made at different ages or under different circumstances. The registry supplies the timing rule but does not report the actual assessment ages, the distribution of follow-up times, or how timing was handled analytically. Those details are not reported in the registry record.
The description notes that some babies could not be assessed in certain domains and were not included in the total analyzed for those domains. This is a form of domain-specific missing outcome information. In general, missing observations can reduce precision and may bias a comparison if the reasons for missingness are related to treatment or to the outcome. Excluding an unassessed participant from one domain does not establish that the participant was excluded from every other domain or from every analysis. The record does not report how many assessments were missing by arm or domain, why they were missing, or whether any statistical method was used to address missing values.
The registry lists 9 outcome measures and 0 analyses. The primary outcome also covers multiple score categories and assessment times; the registry information does not reduce these to one comparison. In general, when investigators examine several outcomes or several domains, the chance of at least one apparently unusual result can increase if all are interpreted as independent opportunities for a finding. Procedures for controlling multiplicity may be used, but their choice depends on the prespecified questions and analysis plan. Whether any multiplicity adjustment was planned or used is not reported in the registry record. The count of listed outcome measures alone does not establish how many statistical tests were performed.
The record gives planning assumptions for an illustrative sample-size calculation based on the observed effect: two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. These are described as planning assumptions, not as the trial’s own design justification. In general, sample-size planning asks how many participants would be needed to detect a specified effect under assumptions about variability, significance level, allocation, and power. A calculation based on an observed effect is a planning illustration and should not be treated as observed power. The registry record does not report the trial’s original sample-size justification, the effect size targeted when the trial was designed, or the assumptions used in that design.
The record does not report an interim-analysis plan, stopping boundaries, a prespecified primary statistical model, covariate adjustment, or a detailed analysis population definition. These are not details that can be reconstructed from the randomized label, the endpoint description, or the enrollment figure. They are not reported in the registry record. Consequently, the design information supports a description of the intended comparison, but not a full appraisal of the statistical analysis conduct.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome includes multiple NNNS domains, and the assessment schedule includes baseline and a later visit specified as one-month post-natal age, between 4-6 weeks of age, or at discharge, whichever came first. The registry notes that some babies could not be assessed in certain domains and were not included in the total analyzed for those domains. Thus, the number contributing to an analysis may differ across domains. Domain-specific sample counts and the reasons for unavailable assessments are not reported in the registry record.
In general, missing outcome data can affect both the precision and the validity of a comparison. If the chance of an unavailable measurement is related to treatment assignment, the outcome, or both, a comparison among observed measurements may not represent the full randomized groups. That is a general concern, not a claim that such a pattern occurred in this trial. The registry does not report whether missing data were imputed, whether sensitivity analyses were performed, or how the analysis addressed participants with incomplete assessments. These methods are not reported in the registry record.
Multiplicity is relevant because the endpoint covers several distinct domains and times, while 9 outcome measures are listed. In general, examining many outcomes can increase the chance of a seemingly notable result arising by chance, so interpretation depends on which outcomes and contrasts were designated in advance and whether adjustment was planned. The registry record lists 0 analyses and does not provide a reported primary result or a multiplicity strategy. It is therefore not possible to determine from the registry record how many comparisons were conducted, which were confirmatory, or whether any adjustment was applied.
The registry does not define whether results were analyzed by randomized assignment, by treatment received, or under another population definition. It also does not report exclusions after randomization or the analysis population for each domain. An intention-to-treat approach, per-protocol analysis, and other analysis populations answer somewhat different questions; none should be attributed to this trial without a report. The analysis populations and handling of multiplicity are not reported in 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 |
|---|---|---|---|
| Clonidine | 9 | 60 | 15.0% |
| Morphine | 15 | 60 | 25.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Clonidine | 1 of 60 |
| Morphine | 0 of 60 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Clonidine | 52 of 60 |
| Morphine | 24 of 60 |
Most frequent serious adverse event terms
| Event term | Organ system | Clonidine | Morphine |
|---|---|---|---|
| Sustained tachycardia | Cardiac disorders | 3 of 60 | 4 of 60 |
| Bradycardia | Cardiac disorders | 4 of 60 | 1 of 60 |
| Hematochezia | Gastrointestinal disorders | 2 of 60 | 2 of 60 |
| Skin lesions | Skin and subcutaneous tissue disorders | 2 of 60 | 1 of 60 |
| Respiratory Distress | Reproductive system and breast disorders | 1 of 60 | 1 of 60 |
| Seizure | Nervous system disorders | 0 of 60 | 2 of 60 |
| Respiratory Syncytial Virus | Infections and infestations | 0 of 60 | 2 of 60 |
| Hypothermia | General disorders | 1 of 60 | 1 of 60 |
| Poor feeding | General disorders | 0 of 60 | 2 of 60 |
| Pyloric stenosis | Gastrointestinal disorders | 0 of 60 | 2 of 60 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Clonidine | Morphine |
|---|---|---|---|
| Finnegan scores consecutively >8 | Nervous system disorders | 24 of 60 | 17 of 60 |
| Phenobarbitol added | Investigations | 15 of 60 | 5 of 60 |
| Adjunct medication added | Investigations | 13 of 60 | 2 of 60 |
Serious events with the highest arm-level rate: sustained tachycardia (6.7%), bradycardia (6.7%), skin lesions (3.3%), hematochezia (3.3%), seizure (3.3%).
The registry reports serious adverse events for 9 of 60 participants at risk in the clonidine group and 15 of 60 at risk in the morphine group. It reports other adverse events for 52 of 60 at risk in the clonidine group and 24 of 60 at risk in the morphine group. Deaths are reported for 1 participant in the clonidine group and 0 in the morphine group. These are event counts as recorded; the figures do not by themselves explain event severity beyond the registry’s serious/other classification, timing, duration, or relationship to treatment.
The serious-event terms listed include Sustained tachycardia, Bradycardia, Skin lesions, Hematochezia, Seizure, and Respiratory Syncytial Virus. The registry lists percentages of 6.7% for Sustained tachycardia, 6.7% for Bradycardia, and 3.3% for each of the other listed terms. The listing does not attribute these term-specific percentages to an arm in the information, so they should not be assigned to either group. Nor should the term percentages be added together: the record does not say whether an individual could contribute more than one event.
In general, safety counts describe what was recorded in the groups at risk, but counts alone do not establish that an intervention caused an event or provide a complete comparison of risk. Interpretation would also depend on event definitions, follow-up, overlap among events, and participant-level context. Those details are not reported in the registry record. These safety figures should be kept distinct from the unreported comparative results for the primary neurobehavioral endpoint.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed randomized comparison of clonidine and morphine in neonates with NAS, with change in NNNS summary scores designated as the primary outcome. It also specifies the dosing descriptions, the assessment schedule, and the use of a 95% Confidence Interval as the stated dispersion measure. These details clarify what the trial was designed to examine. They do not supply the result of that examination.
The primary comparative estimates, arm-specific outcome values, and confidence intervals are not reported in the registry record. No direction, magnitude, or precision of a difference in neurobehavioral performance can therefore be described. The record also does not report a primary-outcome p-value or another test result. It would be inaccurate to infer that the treatments were equivalent, that one had a larger effect, or that any observed difference was statistically significant or clinically important.
Even when continuous outcomes are reported, statistical and practical interpretation are distinct. In general, an estimate describes the observed contrast, while its confidence interval conveys uncertainty; whether an effect matters in practice depends on the outcome’s meaning and context. Here, domain-specific NNNS scores represent different constructs, and the registry states that no cutoff for normal or abnormal performance has been published. The score direction should be interpreted for each construct rather than as a universal scale of benefit.
The listed secondary outcomes are Duration of Treatment and Childhood Behavior Checklist 1.5-5 T-Scores, but comparative results for them are not reported in the registry information. The primary endpoint is an early neurobehavioral assessment, and the record does not present long-term developmental findings. A stated long-term research goal in the brief summary is not evidence that a long-term outcome was demonstrated in this trial.
Safety counts are available, but those counts do not fill the gap in primary efficacy reporting and should not be used to infer a neurobehavioral effect. Likewise, the completed status and the enrollment of 120 do not establish how precise the unreported treatment comparison would be. The appropriate conclusion is limited to the available record: the trial’s question and design are described, while its primary comparative findings and important analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a registered research question and a reported result. The record clearly identifies a randomized comparison, the two interventions, the target population, and a multidomain primary outcome. Yet those design details cannot answer the treatment-comparison question without outcome estimates. Readers need the arm results, the between-arm contrast, and its uncertainty to judge what the observed data show.
The endpoint also illustrates why outcome structure matters. NNNS summary scores span several constructs, and a higher score means more of the particular construct rather than a universal improvement or worsening. The record states that no normal/abnormal cutoff has been published. Statistical interpretation therefore depends on identifying the domain, understanding its direction, and keeping each estimate tied to the measure it represents.
Missing domain assessments and multiple outcomes also matter for interpretation. The registry says that some babies could not be assessed in certain domains and were not included in the total for those domains. In general, readers need to know the amount and pattern of missingness, the analysis population, and the approach to multiple comparisons to assess how robust results may be. Those details are not reported in the registry record. The number of listed outcome measures does not, on its own, tell readers how many analyses were conducted or how findings were selected.
Finally, a planning illustration based on an observed effect is distinct from the original design rationale and from evidence of achieved power. The registry describes assumptions for such an illustration but does not report the original sample-size justification. Keeping these distinctions clear prevents a design label, a planning calculation, or a study status from being mistaken for a treatment result. The record is useful for identifying the intended question, but the absent comparative outcome estimates limit statistical conclusions.
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 interpreting this trial from the registry record is the absence of reported primary outcome results. There are no arm-specific NNNS scores, mean changes, between-arm estimates, confidence intervals, or p-values in the information. The outcome question therefore cannot be answered statistically from this record. The registry also reports 0 analyses, so no inferential result is available to assess.
The primary endpoint is multidomain, but the registry information does not present a separate result for each domain or clarify which domain-level comparisons, if any, were prespecified as primary. It states that some babies could not be assessed in certain domains and were omitted from the total analyzed for those domains, but does not report domain-specific sample counts, the pattern or reasons for missing assessment, or how missingness was handled. This limits assessment of the completeness and comparability of the outcome data.
The follow-up timing includes a baseline assessment and a later measurement at one-month post-natal age, between 4-6 weeks of age, or at discharge, whichever came first. The record does not state the actual timing distribution or how differences in timing were incorporated into analysis. Further details about the statistical model, analysis population, multiplicity procedures, interim analyses, and original sample-size justification are not reported in the registry record.
The registry’s masking label does not specify which roles were masked or how masking was maintained. The arm descriptions give dose and dosing intervals but do not describe further treatment procedures. Safety reporting includes group counts and a list of serious-event terms, but the term-specific percentages are not attributed to an arm in the reported information. Event timing, overlap, and attribution are not reported in the registry record. These limitations concern what can be assessed from the record and should not be mistaken for evidence that a particular method or event did or did not occur.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain — NCT03396588.
- Registry record last updated 2025-05-23; status last verified 2025-05.
- Results first posted 2025-05-23.
- 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
NCT03396588 is recorded as a completed phase 3, randomized, quadruple-masked, parallel-group trial with enrollment of 120. It compares clonidine, described as 1mcg/kg/dose with a dosing interval of 3 or 4 hours, with morphine, described as 0.06 mg/kg/dose with a dosing interval of 3 or 4 hours, for neonates with neonatal abstinence syndrome.
The primary outcome is change in mean NNNS summary scores, assessed at baseline and at one-month post-natal age, between 4-6 weeks of age, or at discharge, whichever came first. The record identifies a 95% Confidence Interval as the dispersion measure and notes that some babies were not assessed in certain domains. Duration of Treatment and Childhood Behavior Checklist 1.5-5 T-Scores are listed as secondary outcomes.
The registry record does not report comparative primary outcome results, analysis details, or a multiplicity strategy. It therefore describes the trial question and design but does not support a conclusion about comparative neurobehavioral outcomes.