Neonatal Abstinence SyndromePhase 2NCT03670160
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
A Phase 2 study testing Phenobarbital and Clonidine in people with Neonatal Abstinence Syndrome, run by University of Tennessee Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS). Read more about this study
- Who is it for?
- Ages 35 weeks and older
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Phenobarbital and Clonidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 May 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants greater than or equal to 35 weeks gestation age
- Admitted to the neonatal intensive care unit
- Failed monotherapy with morphine sulfate therapy
Who cannot join
- Neonatal abstinence syndrome due to iatrogenic causes
- Unable to take oral medications at any point during their treatment
- Infants in the custody of the Department of Child Protective Services with no legal guardian identified at the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
About this study
The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS).
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Phenobarbital, Clonidine
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenobarbitalDrug
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.
ClonidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Phenobarbital | Active comparator | Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization. Receives: Drug: Phenobarbital |
| Clonidine | Active comparator | 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. Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Initiation of Adjunctive Therapy Until Hospital Discharge
Number of days from initiation of adjunctive therapy until hospital discharge
Measured: From date of randomization until hospital discharge, up to 4 months
Secondary outcomes (4)
Length of Stay
Number of days of hospital admission
Measured: From date of randomization until hospital discharge, up to 4 months
Length of Oral Morphine Sulfate Therapy
Number of days of oral morphine sulfate therapy
Measured: From date of randomization until hospital discharge, up to 4 months
Number of Patients Requiring Triple Therapy
Number of patients requiring a third agent to control withdrawal symptoms
Measured: From date of randomization until hospital discharge, up to 4 months
Readmission Rate
Number of patients readmitted to the hospital within 30 days of hospital discharge or discontinuation of phenobarbital.
Measured: From date of randomization until 30 days after hospital discharge or discontinuation of phenobarbital, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Oct 2018
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carrie Brusseau, PharmD, Principal investigator, University of Tennessee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670160
- Sponsor's protocol ID
- UHS-OB-0001
- Status last verified
- Nov 2021
- First submitted
- 5 Sep 2018
- Last updated
- 10 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
- ClinicalTrials.gov ID
- NCT03670160
- Acronym / sponsor ID
- UHS-OB-0001
- Conditions
- Neonatal Abstinence Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Tennessee Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Posted 9 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenobarbital | Active comparator | Drug: PhenobarbitalPhenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization. |
| Clonidine | Active comparator | Drug: ClonidineClonidine 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. |
Who may qualify
- Ages
- 35 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Infants greater than or equal to 35 weeks gestation age
- Admitted to the neonatal intensive care unit
- Failed monotherapy with morphine sulfate therapy
Key exclusion criteria (3 listed)
- Neonatal abstinence syndrome due to iatrogenic causes
- Unable to take oral medications at any point during their treatment
- Infants in the custody of the Department of Child Protective Services with no legal guardian identified at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenobarbitalPhenobarbital 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. | Drug | Phenobarbital |
| ClonidineClonidine 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. | Drug | Clonidine |
Primary outcome
Time From Initiation of Adjunctive Therapy Until Hospital Discharge
Time frame: From date of randomization until hospital discharge, up to 4 months
Number of days from initiation of adjunctive therapy until hospital discharge
4 secondary outcomes
Length of Stay
Time frame: From date of randomization until hospital discharge, up to 4 months
Length of Oral Morphine Sulfate Therapy
Time frame: From date of randomization until hospital discharge, up to 4 months
Number of Patients Requiring Triple Therapy
Time frame: From date of randomization until hospital discharge, up to 4 months
Readmission Rate
Time frame: From date of randomization until 30 days after hospital discharge or discontinuation of phenobarbital, up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Brusseau, PharmD principal investigator
University of Tennessee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phenobarbital and Clonidine in people with Neonatal Abstinence Syndrome, run by University of Tennessee Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From Initiation of Adjunctive Therapy Until Hospital Discharge (time frame: From date of randomization until hospital discharge, up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.