Comparison · NCT03670160-c77c0803
Phenobarbital vs Clonidine: Number of Patients Requiring Triple Therapy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Phenobarbital vs Clonidine: Number of Patients Requiring Triple Therapy. Trial comparisons, record NCT03670160-c77c0803. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03670160-c77c0803
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.364 | 0.152 | 0.646 | wilson | |
| Risk in group 2 | 0.714 | 0.454 | 0.883 | wilson | |
| Risk difference, group 1 minus group 2 | -0.351 | -0.621 | 0.0339 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.509 | 0.218 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 0.229 | 0.0422 | 1.24 | log | |
| Number needed to treat, for one fewer participant with the outcome on Phenobarbital than on Clonidine | 2.85 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Phenobarbital | Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.~Phenobarbital: Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge. | 4 | 11 | OG000 |
| Group 2 | Clonidine | Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be continued to achieve control of NAS symptoms. Clonidine may be weaned after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.~Clonidine: Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine. | 10 | 14 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients Requiring Triple Therapy
- Description
- Number of patients requiring a third agent to control withdrawal symptoms
- Time frame
- From date of randomization until hospital discharge, up to 4 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
- NCT number
- NCT03670160
- Phases
- PHASE2
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Phenobarbital, Clonidine
- Lead sponsor
- University of Tennessee Medical Center
- Results first posted
- 2021-11-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03670160?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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