Trial · NCT04214834
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
NCT04214834, Phase 3, Active not recruiting, Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program; results first posted 2025-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS). Trials, record NCT04214834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04214834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
- NCT number
- NCT04214834
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 189 participants, actual
- Lead sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
- Conditions
- Neonatal Opioid Withdrawal Syndrome
- Interventions
- Morphine, Methadone
- First posted
- 2020-01-02
- Last updated
- 2026-06-30
- Results first posted
- 2025-03-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Days of Opioid Treatment From First Wean to Cessation | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | The number of days of opioid treatment (used as primary treatment), including escalation, resumption, and spot treatment, from the first weaning dose to cessation of opioid. From the start of opioid study medication until weaning. Infants will exit the study intervention without unblinding (remain in the trial) if they have not weaned off study drug by 35 days (inclusive of the 35th day) form the first weaning dose. Outcome will be truncated at 35 days regardless of the study arm.We note that primary outcome data is missing for 4 participants resulting in total sample of 185 for the primary analysis. |
| Secondary | Days of Opioid Treatment From First Wean to Cessation Among Infants That Were Not Withdrawn in High Enrolling Centers | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | The number of days of opioid treatment from first wean to cessation among infants that were not withdrawn in high enrolling centers |
| Secondary | Days of Opioid Treatment From First Wean to Cessation Among High Enrolling Centers | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | The number of days of opioid treatment from first wean to cessation among high enrolling centers |
| Secondary | Days of Opioid Treatment From First Wean to Cessation Among Infants That Were Not Withdrawn | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | The number of days of opioid treatment from first wean to cessation among infants that were not withdrawn |
| Other | Primary Outcome by Sex | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | The number of days of opioid treatment (used as primary treatment), including escalation, resumption, and spot treatment, from the first weaning dose to cessation of opioid, by sex |
| Other | Primary Outcome by Race | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | The number of days of opioid treatment (used as primary treatment), including escalation, resumption, and spot treatment, from the first weaning dose to cessation of opioid, by race |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Days of Opioid Treatment From First Wean to Cessation | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEAN |
| SECONDARY | Days of Opioid Treatment From First Wean to Cessation Among Infants That Were Not Withdrawn in High Enrolling Centers | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEAN |
| SECONDARY | Days of Opioid Treatment From First Wean to Cessation Among High Enrolling Centers | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEAN |
| SECONDARY | Days of Opioid Treatment From First Wean to Cessation Among Infants That Were Not Withdrawn | From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm. | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | days | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Days of Opioid Treatment From First Wean to Cessation | Rapid Wean | 9.3 | Standard Deviation 6.3 | days | |
| Days of Opioid Treatment From First Wean to Cessation | Slow Wean | 11.7 | Standard Deviation 6.1 | days | |
| Days of Opioid Treatment From First Wean to Cessation Among Infants That Were Not Withdrawn in High Enrolling Centers | Rapid Wean | 8.1 | Standard Deviation 4.9 | days | |
| Days of Opioid Treatment From First Wean to Cessation Among Infants That Were Not Withdrawn in High Enrolling Centers | Slow Wean | 10.5 | Standard Deviation 4.2 | days | |
| Days of Opioid Treatment From First Wean to Cessation Among High Enrolling Centers | Rapid Wean | 9 | Standard Deviation 5.9 | days | |
| Days of Opioid Treatment From First Wean to Cessation Among High Enrolling Centers | Slow Wean | 11.3 | Standard Deviation 5.7 | days | |
| Days of Opioid Treatment From First Wean to Cessation Among Infants That Were Not Withdrawn | Rapid Wean | 8 | Standard Deviation 4.8 | days | |
| Days of Opioid Treatment From First Wean to Cessation Among Infants That Were Not Withdrawn | Slow Wean | 10.7 | Standard Deviation 4.1 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rapid Wean | 98 | |
| Overall Study | STARTED | Slow Wean | 91 | |
| Overall Study | COMPLETED | Rapid Wean | 94 | |
| Overall Study | COMPLETED | Slow Wean | 91 | |
| Overall Study | NOT COMPLETED | Rapid Wean | 4 | |
| Overall Study | NOT COMPLETED | Slow Wean | 0 |
Source ClinicalTrials.gov
Adverse events12
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 | Inguinal hernia/repair | Gastrointestinal disorders | Rapid Wean | 0 | 98 | 0 |
| other | Inguinal hernia/repair | Gastrointestinal disorders | Slow Wean | 1 | 91 | 1 |
| other | Over-sedation | Nervous system disorders | Rapid Wean | 1 | 98 | 1 |
| other | Over-sedation | Nervous system disorders | Slow Wean | 0 | 91 | 0 |
| other | Respiratory disturbances | Respiratory, thoracic and mediastinal disorders | Rapid Wean | 2 | 98 | 2 |
| other | Respiratory disturbances | Respiratory, thoracic and mediastinal disorders | Slow Wean | 3 | 91 | 3 |
| serious | Epidural hematoma | Nervous system disorders | Rapid Wean | 0 | 98 | 0 |
| serious | Epidural hematoma | Nervous system disorders | Slow Wean | 1 | 91 | 1 |
| serious | Seizure | Nervous system disorders | Rapid Wean | 1 | 98 | 1 |
| serious | Seizure | Nervous system disorders | Slow Wean | 0 | 91 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rapid Wean | 0 | 98 |
| Total, all-cause mortality | Slow Wean | 0 | 91 |
| Total, other adverse events | Rapid Wean | 3 | 98 |
| Total, other adverse events | Slow Wean | 4 | 91 |
| Total, serious adverse events | Rapid Wean | 1 | 98 |
| Total, serious adverse events | Slow Wean | 1 | 91 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rapid Wean vs Slow Wean: deaths from any cause | Trial comparisons |
| Rapid Wean vs Slow Wean: 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/NCT04214834
GET https://conductscience.org/api/trials/v1/NCT04214834/registered