Trial · NCT03670160
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
NCT03670160, Phase 2, Completed, University of Tennessee Medical Center; results first posted 2021-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome. Trials, record NCT03670160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03670160
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
- NCT number
- NCT03670160
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- University of Tennessee Medical Center
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Phenobarbital, Clonidine
- First posted
- 2018-09-13
- Last updated
- 2021-11-10
- Results first posted
- 2021-11-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Initiation of Adjunctive Therapy Until Hospital Discharge | From date of randomization until hospital discharge, up to 4 months | Number of days from initiation of adjunctive therapy until hospital discharge |
| Secondary | Length of Stay | From date of randomization until hospital discharge, up to 4 months | Number of days of hospital admission |
| Secondary | Length of Oral Morphine Sulfate Therapy | From date of randomization until hospital discharge, up to 4 months | Number of days of oral morphine sulfate therapy |
| Secondary | Number of Patients Requiring Triple Therapy | From date of randomization until hospital discharge, up to 4 months | Number of patients requiring a third agent to control withdrawal symptoms |
| Secondary | Readmission Rate | From date of randomization until 30 days after hospital discharge or discontinuation of phenobarbital, up to 6 months | Number of patients readmitted to the hospital within 30 days of hospital discharge or discontinuation of phenobarbital. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Initiation of Adjunctive Therapy Until Hospital Discharge | From date of randomization until hospital discharge, up to 4 months | Days | MEAN | |
| SECONDARY | Length of Stay | From date of randomization until hospital discharge, up to 4 months | Days | MEAN | |
| SECONDARY | Length of Oral Morphine Sulfate Therapy | From date of randomization until hospital discharge, up to 4 months | Days | MEAN | |
| SECONDARY | Number of Patients Requiring Triple Therapy | From date of randomization until hospital discharge, up to 4 months | participants | NUMBER | |
| SECONDARY | Readmission Rate | From date of randomization until 30 days after hospital discharge or discontinuation of phenobarbital, up to 6 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Initiation of Adjunctive Therapy Until Hospital Discharge | Phenobarbital | 20 | Standard Deviation 12.6 | Days | |
| Time From Initiation of Adjunctive Therapy Until Hospital Discharge | Clonidine | 33.8 | Standard Deviation 14.3 | Days | |
| Length of Stay | Phenobarbital | 31 | Standard Deviation 9.96 | Days | |
| Length of Stay | Clonidine | 41.78 | Standard Deviation 10.94 | Days | |
| Length of Oral Morphine Sulfate Therapy | Phenobarbital | 25.45 | Standard Deviation 6.95 | Days | |
| Length of Oral Morphine Sulfate Therapy | Clonidine | 34.36 | Standard Deviation 10.18 | Days | |
| Number of Patients Requiring Triple Therapy | Phenobarbital | 4 | participants | ||
| Number of Patients Requiring Triple Therapy | Clonidine | 10 | participants | ||
| Readmission Rate | Phenobarbital | 0 | Participants | ||
| Readmission Rate | Clonidine | 0 | Participants |
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 | Phenobarbital | 11 | |
| Overall Study | STARTED | Clonidine | 14 | |
| Overall Study | COMPLETED | Phenobarbital | 11 | |
| Overall Study | COMPLETED | Clonidine | 14 | |
| Overall Study | NOT COMPLETED | Phenobarbital | 0 | |
| Overall Study | NOT COMPLETED | Clonidine | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Hypotension | Cardiac disorders | Phenobarbital | 0 | 11 | 0 |
| other | Hypotension | Cardiac disorders | Clonidine | 2 | 14 | 2 |
| other | Hypertension | Cardiac disorders | Phenobarbital | 0 | 11 | 0 |
| other | Hypertension | Cardiac disorders | Clonidine | 1 | 14 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phenobarbital | 0 | 11 |
| Total, all-cause mortality | Clonidine | 0 | 14 |
| Total, other adverse events | Phenobarbital | 0 | 11 |
| Total, other adverse events | Clonidine | 3 | 14 |
| Total, serious adverse events | Phenobarbital | 0 | 11 |
| Total, serious adverse events | Clonidine | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phenobarbital vs Clonidine: Readmission Rate | Trial comparisons |
| Phenobarbital vs Clonidine: Number of Patients Requiring Triple Therapy | Trial comparisons |
| Phenobarbital vs Clonidine: deaths from any cause | Trial comparisons |
| Phenobarbital vs Clonidine: 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/NCT03670160
GET https://conductscience.org/api/trials/v1/NCT03670160/registered