Trial · NCT01958476
Improving Outcomes in Neonatal Abstinence Syndrome
NCT01958476, Phase 3, Completed, Tufts Medical Center; results first posted 2019-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Improving Outcomes in Neonatal Abstinence Syndrome. Trials, record NCT01958476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01958476
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Outcomes in Neonatal Abstinence Syndrome
- NCT number
- NCT01958476
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 117 participants, actual
- Lead sponsor
- Tufts Medical Center
- Conditions
- Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
- Interventions
- Neonatal Morphine Solution, Methadone, Phenobarbital
- First posted
- 2013-10-09
- Last updated
- 2019-10-15
- Results first posted
- 2019-10-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Hospital Stay (LOS) | Participants will be monitored during their entire hospitalization, expected mean 22 days. | Participants were monitored for the duration of their hospitalization, an expected mean of 22 days. |
| Secondary | Length of Hospital Stay (LOS) Due to Neonatal Abstinence Syndrome (NAS) | Participants were monitored for the duration of their hospitalization, expected mean 22 days. | Participants were monitored for the duration of their hospitalization attributable to NAS only. |
| Secondary | Length of Treatment (LOT) | Participants were monitored for the duration of their hospitalization. | Total number of days infant treated with replacement opioids while admitted to the hospital. |
| Secondary | Maximum Daily Dose of Replacement Opioid | Participants were monitored for the duration of their hospitalization. | Maximum daily dose of neonatal morphine solution or methadone during the hospitalization |
| Secondary | Mean Finnegan Score (FS) | Participants were monitored during their entire hospitalization | Mean Finnegan withdrawal score during the duration of hospitalization. |
| Secondary | Number of Infants Needing a Second NAS Medication | Participants were monitored for the duration of their hospitalization, an average of 22 days. | Number of infants treated with a second medication following protocol, phenobarbital. If the Finnegan Score remained elevated (still scored ≥8 two times consecutively, or still scored once ≥12) despite increasing to a predetermined maximal opioid dose (methadone or morphine), phenobarbital was administered (20-mg/kg loading dose followed by 4-5 mg/kg daily). |
| Secondary | Growth Outcome: Weight Change From Birth to 18 Months | Birth to 18 month follow-up visit | Growth outcome weight (lbs) depicted as difference in averaged weights from birth to 18 month follow-up visit. Standard deviations were averaged between birth and 18 mo time points. |
| Secondary | Growth Outcome: Head Circumference at 18 Months | 18 month follow-up visit | Average head circumference growth outcome at 18 month follow-up visit. |
| Secondary | Maximum Finnegan Score | Participants monitored for the duration of their hospitalization. | Maximum Finnegan score during the hospitalization |
| Secondary | Growth Outcome: Length at 18 Months | 18 month follow-up visit | Average length (cm) at 18 month follow-up visit. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Length of Hospital Stay (LOS) | Participants will be monitored during their entire hospitalization, expected mean 22 days. | Includes infants requiring treatment for NAS who were randomized to either methadone or morphine study intervention. Analysis does not include Standard Clinical Care cohort. | days | MEAN |
| SECONDARY | Length of Hospital Stay (LOS) Due to Neonatal Abstinence Syndrome (NAS) | Participants were monitored for the duration of their hospitalization, expected mean 22 days. | Includes infants requiring treatment for NAS who were randomized to either methadone or morphine study intervention. Analysis does not include Standard Clinical Care cohort. | days | MEAN |
| SECONDARY | Length of Treatment (LOT) | Participants were monitored for the duration of their hospitalization. | Includes infants requiring treatment for NAS who were randomized to either methadone or morphine study intervention. Analysis does not include Standard Clinical Care cohort. | days | MEAN |
| SECONDARY | Maximum Daily Dose of Replacement Opioid | Participants were monitored for the duration of their hospitalization. | Data were not collected due to insufficient funding to carry out data collection. | ||
| SECONDARY | Mean Finnegan Score (FS) | Participants were monitored during their entire hospitalization | Data were not collected due to insufficient funding to carry out data collection. | ||
| SECONDARY | Number of Infants Needing a Second NAS Medication | Participants were monitored for the duration of their hospitalization, an average of 22 days. | Includes infants requiring treatment for NAS who were randomized to either methadone or morphine study intervention. Analysis does not include Standard Clinical Care cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Growth Outcome: Weight Change From Birth to 18 Months | Birth to 18 month follow-up visit | Participants who were continuously enrolled and attended the 18 month follow-up visit for developmental and growth measures. | lbs | MEAN |
| SECONDARY | Growth Outcome: Head Circumference at 18 Months | 18 month follow-up visit | Participants who were continuously enrolled and attended the 18 month follow-up visit for developmental and growth measures. | cm | MEAN |
| SECONDARY | Maximum Finnegan Score | Participants monitored for the duration of their hospitalization. | Data were not collected due to insufficient funding to carry out data collection. | ||
| SECONDARY | Growth Outcome: Length at 18 Months | 18 month follow-up visit | Participants who were continuously enrolled and attended the 18 month follow-up visit for developmental and growth measures. | cm | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Length of Hospital Stay (LOS) | Methadone | 21.8 | Standard Deviation 15 | days | |
| Length of Hospital Stay (LOS) | Neonatal Morphine Solution | 23.2 | Standard Deviation 8.8 | days | |
| Length of Hospital Stay (LOS) Due to Neonatal Abstinence Syndrome (NAS) | Methadone | 18.9 | Standard Deviation 7.9 | days | |
| Length of Hospital Stay (LOS) Due to Neonatal Abstinence Syndrome (NAS) | Neonatal Morphine Solution | 21.1 | Standard Deviation 6.9 | days | |
| Length of Treatment (LOT) | Methadone | 14.7 | Standard Deviation 8.0 | days | |
| Length of Treatment (LOT) | Neonatal Morphine Solution | 16.6 | Standard Deviation 6.9 | days | |
| Number of Infants Needing a Second NAS Medication | Methadone | 10 | Participants | ||
| Number of Infants Needing a Second NAS Medication | Neonatal Morphine Solution | 17 | Participants | ||
| Growth Outcome: Weight Change From Birth to 18 Months | Methadone | 19.1 | Standard Deviation 2.5 | lbs | |
| Growth Outcome: Weight Change From Birth to 18 Months | Neonatal Morphine Solution | 18.7 | Standard Deviation 2.8 | lbs |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methadone | 59 | |
| Overall Study | STARTED | Neonatal Morphine Solution | 58 | |
| Overall Study | COMPLETED | Methadone | 58 | |
| Overall Study | COMPLETED | Neonatal Morphine Solution | 58 | |
| Overall Study | NOT COMPLETED | Methadone | 1 | |
| Overall Study | NOT COMPLETED | Neonatal Morphine Solution | 0 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Apnea and shallow breathing episodes | Respiratory, thoracic and mediastinal disorders | Methadone | 1 | 58 | 1 |
| other | Apnea and shallow breathing episodes | Respiratory, thoracic and mediastinal disorders | Neonatal Morphine Solution | 0 | 58 | 0 |
| other | Excessive sleepiness/somnolence | Investigations | Methadone | 4 | 58 | 4 |
| other | Excessive sleepiness/somnolence | Investigations | Neonatal Morphine Solution | 2 | 58 | 2 |
| other | Lethargy | Investigations | Methadone | 0 | 58 | 0 |
| other | Lethargy | Investigations | Neonatal Morphine Solution | 1 | 58 | 1 |
| other | Hypothermia | Investigations | Methadone | 2 | 58 | 2 |
| other | Hypothermia | Investigations | Neonatal Morphine Solution | 0 | 58 | 0 |
| other | Stridor/desaturation/shalllow breathing | Respiratory, thoracic and mediastinal disorders | Methadone | 2 | 58 | 2 |
| other | Stridor/desaturation/shalllow breathing | Respiratory, thoracic and mediastinal disorders | Neonatal Morphine Solution | 0 | 58 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methadone | 0 | 58 |
| Total, all-cause mortality | Neonatal Morphine Solution | 0 | 58 |
| Total, other adverse events | Methadone | 8 | 58 |
| Total, other adverse events | Neonatal Morphine Solution | 6 | 58 |
| Total, serious adverse events | Methadone | 5 | 58 |
| Total, serious adverse events | Neonatal Morphine Solution | 3 | 58 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA032889 | Improving Outcome in Neonatal Abstinence Syndrome | DAVIS, JONATHAN M.; LESTER, BARRY M. | TUFTS MEDICAL CENTER | NATIONAL INSTITUTE ON DRUG ABUSE | 2012 to 2015 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Methadone vs Neonatal Morphine Solution: Number of Infants Needing a Second NAS Medication | Trial comparisons |
| Methadone vs Neonatal Morphine Solution: Number of Infants Needing a Dose Increase | Trial comparisons |
| Methadone vs Neonatal Morphine Solution: deaths from any cause | Trial comparisons |
| Methadone vs Neonatal Morphine Solution: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01958476
GET https://conductscience.org/api/trials/v1/NCT01958476/results?page=2