Comparison · NCT01958476-8b6843aa
Methadone vs Neonatal Morphine Solution: Number of Infants Needing a Dose Increase
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Methadone vs Neonatal Morphine Solution: Number of Infants Needing a Dose Increase. Trial comparisons, record NCT01958476-8b6843aa. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01958476-8b6843aa
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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 | 0.379 | 0.266 | 0.508 | wilson | |
| Risk in group 2 | 0.483 | 0.359 | 0.608 | wilson | |
| Risk difference, group 1 minus group 2 | -0.103 | -0.273 | 0.0749 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.786 | 0.514 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 0.655 | 0.313 | 1.37 | log | |
| Number needed to treat, for one fewer participant with the outcome on Methadone than on Neonatal Morphine Solution | 9.67 | 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 | Methadone | Infants randomized to this group will receive methadone oral solution (0.4mg/mL) for first line therapy. Infants will be scored using the standardized Finnegan scoring system and will be initiated on treatment if they have 2 consecutive scores greater than or equal to 8 or 1 score greater than or equal to 12. Dosing will be weight and symptom based. Starting doses will range from 0.3mg/kg/day to 0.9mg/kg/day divided every 8 hours depending on the severity of the Finnegan scores. To maintain blinding of the two study arms, a double dummy design will be used - each infant will receive both methadone/placebo study drug at 0.4 mg/mL and a morphine/placebo study drug at 0.2 mg/mL. Doses will be increased to a maximum of 0.9mg/kg/day for continued scores generally \>8 caused primarily by worsening NAS as needed. Infants will be weaned by 10% of the maximum dose once every 24-48 hours and the medication will be discontinued once at 25% of the maximum dose. | 22 | 58 | OG000 |
| Group 2 | Neonatal Morphine Solution | Infants randomized to this arm will receive neonatal morphine solution (0.2mg/mL) for first line therapy. Infants will be scored using the standardized Finnegan scoring system and will be initiated on treatment if they have 2 consecutive scores greater than or equal to 8 or 1 score greater than or equal to 12. Dosing will be weight and symptom based. A double dummy design will be used - each infant will be ordered for both a methadone/placebo study drug at 0.4 mg/mL and a morphine/placebo study drug at 0.2 mg/mL. Starting doses will range from 0.3mg/kg/day to 0.9mg/kg/day divided every 4 hours depending on the severity of the Finnegan scores. Doses will be increased to a maximum of 0.9mg/kg/day for continued scores generally \>8 caused primarily by worsening NAS. Infants will be weaned by 10% of the maximum dose once every 24 - 48 hours and the medication will be discontinued once at 25% of the maximum dose. | 28 | 58 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- POST_HOC
- Title
- Number of Infants Needing a Dose Increase
- Description
One Finnegan score ≥12, or two consecutive scores ≥8 affirms the requirement for pharmacological treatment or increasing treatment dosage. If the infant continued to have two consecutive Finnegan Scores ≥8 two times consecutively, or one ≥12, the dose was increased to the next level. (Level I: 0.3 mg/kg/day) (Level II: 0.5 mg/kg/day) (Level III: 0.7 mg/kg/day)~A higher Finnegan score indicates greater severity of NAS (min 0, max 50).
- Time frame
- Participants were monitored for the duration of their hospitalization, an average of 22 days.
- Population
Source ClinicalTrials.gov
Trial
- Title
- Improving Outcomes in Neonatal Abstinence Syndrome
- NCT number
- NCT01958476
- Phases
- PHASE3
- Conditions
- Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
- Interventions
- Neonatal Morphine Solution, Methadone, Phenobarbital
- Lead sponsor
- Tufts Medical Center
- Results first posted
- 2019-10-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01958476?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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