Neonatal Abstinence SyndromePhase 4NCT03762317

Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

A Phase 4 study testing Clonidine in people with Neonatal Abstinence Syndrome, run by Hennepin County Medical Center, Minneapolis at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the management of term and near term infants with neonatal… Read more about this study

Who is it for?: Ages 36 to 45 weeks
Conditions the study is for: Neonatal Abstinence Syndrome
What is being tested?: Clonidine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 30 Apr 2018to 12 Dec 2018
Phase: Phase 4
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 36 to 45 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

Requiring neonatal intensive care unit (NICU) admission for management of neonatal abstinence syndrome
Gestational age greater than or equal to 36 weeks
Less than or equal to 48 hours of treatment with morphine for NAS

Who cannot join

Presence of seizures
Congenital malformations, genetic syndromes or the presence of TORCH infections
Major medical problems
Heart rate and/or blood pressure instability

Trial locations and contacts

1 site in 1 country.

United States1 site

Hennepin County Medical Center
Minneapolis, Minnesota, 55415

Other trials in United States

About this study

Official title: Clonidine as Adjunct to Morphine in the Management of Term and Near Term Infants With Neonatal Abstinence Syndrome

Read the detailed description

Neonatal abstinence syndrome (NAS) is an emerging epidemic and has lead to a tremendous increase in cost of medical care. Opioids are the mainstay of treatment for NAS although there are concerns about possible short-term and long-term effects including but not limited to adverse neurodevelopmental outcomes. Other drugs such as clonidine, phenobarbitone, methadone and buprenorphine have been evaluated to limit the postnatal exposure to opioids in these infants. Clonidine is an alpha 2 receptor and can lessen withdrawal manifestations. The addition of clonidine at 6 µg/kilogram/day to morphine in the management of NAS has been shown to reduce the duration of pharmacotherapy by about 27% in a previous study.

A recent pilot study reported reduction of treatment duration for NAS with clonidine (12 µg/kilogram/day) monotherapy as compared to morphine monotherapy. The study reported no adverse effects in study subjects at the doses used in the study. The investigators hypothesize that there will be a minimum of 30% reduction in the treatment duration with 12 µg/kilogram/day clonidine used as adjuncts to standard morphine treatment as compared to morphine monotherapy in the management of term and near term infants with NAS

Conditions: Neonatal Abstinence Syndrome
Being tested: Clonidine, Placebo
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.

ClonidineDrug
clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine
PlaceboDrug
Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine

Study groups in NCT03762317
Study group	Role	What they receive
clonidine	Active comparator	Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period Receives: Drug: Clonidine
Placebo	Placebo comparator	Placebo solution will be given for the duration of the study period Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Pharmacotherapy for NAS
The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped
Measured: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

Secondary outcomes (5)

Duration of Hospital Stay
Number of days spent in the hospital
Measured: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Maximum Dose of Morphine Used
The maximum dose of morphine in mg/kg used for symptom control
Measured: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Average Daily Dose of Oral Morphine Over Hospital Stay
The average daily dose of morphine used throughout study period in mg/kg/day
Measured: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Total Number of Episodes of Heart Rate Variability (Heart Beats/Min)
Number of episodes of bradycardia (Heart rate < 60/min for a minimum of 20 seconds and not associated with apnea or signs of reflux such as emesis, regurgitation of milk into the mouth or nose, arching while feeding, number of episodes of tachycardia (Heart rate > 200/min) and not related to pain and/or agitation
Measured: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Total Number of Episodes of Blood Pressure (mm of Hg) Variability
Number of episodes of hypotension (blood pressure < 5th percentile for age) and hypertension (blood pressure > 95th percentile for age)
Measured: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 201812 Dec 2018

First posted3 Dec 2018
Study start30 Apr 2018
Primary completion12 Dec 2018
Study completion12 Dec 2018

Why it stopped: Study was initially suspended due to IND application and later terminated due to the difficulty of obtaining consent during COVID period

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03762317
Sponsor's protocol ID: NAS
Status last verified: Jan 2023
First submitted: 8 Nov 2017
Last updated: 10 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome

All Neonatal Abstinence Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clonidine as Adjunct to Morphine in the Management of Term and Near Term Infants With Neonatal Abstinence Syndrome
ClinicalTrials.gov ID: NCT03762317
Acronym / sponsor ID: NAS
Conditions: Neonatal Abstinence Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was initially suspended due to IND application and later terminated due to the difficulty of obtaining consent during COVID period
Enrolment: 10 participants (actual)
Lead sponsor: Hennepin County Medical Center, MinneapolisUniversity, hospital or other
Study start: 30 Apr 2018 (actual)
Primary completion: 12 Dec 2018 (actual)
Study completion: 12 Dec 2018 (actual)
First posted: 3 Dec 2018 (actual)
Results: Posted 10 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
clonidine	Active comparator	Drug: ClonidineClonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period
Placebo	Placebo comparator	Drug: PlaceboPlacebo solution will be given for the duration of the study period

Who may qualify

Ages: 36 to 45 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Requiring neonatal intensive care unit (NICU) admission for management of neonatal abstinence syndrome
Gestational age greater than or equal to 36 weeks
Less than or equal to 48 hours of treatment with morphine for NAS

Key exclusion criteria (4 listed)

Presence of seizures
Congenital malformations, genetic syndromes or the presence of TORCH infections
Major medical problems
Heart rate and/or blood pressure instability

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
Clonidineclonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine	Drug	clonidine
PlaceboPlacebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine	Drug	Placebo

Primary outcome

Duration of Pharmacotherapy for NAS
Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped

5 secondary outcomes

Duration of Hospital Stay
Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Maximum Dose of Morphine Used
Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Average Daily Dose of Oral Morphine Over Hospital Stay
Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Total Number of Episodes of Heart Rate Variability (Heart Beats/Min)
Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Total Number of Episodes of Blood Pressure (mm of Hg) Variability
Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

Results and safety

Results posted to the registry on 10 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clonidine	5	5
Placebo	5	5

Primary outcome: Duration of Pharmacotherapy for NAS

Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days. Mean (Standard Deviation). Unit: days

Measure	Clonidine n = 5	Placebo n = 5
Value	30.2 (18.6)	25.6 (14.7)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clonidine	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Placebo	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Neonatal Abstinence Syndrome

Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome

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.

kunal gupta principal investigator

Hennepin County Medical Center, Minneapolis

vinay sharma principal investigator

Hennepin County Medical Center, Minneapolis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clonidine in people with Neonatal Abstinence Syndrome, run by Hennepin County Medical Center, Minneapolis 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 4 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: stopped early, as of the sponsor's last update on 10 Feb 2023. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 10 Feb 2023). 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?

Duration of Pharmacotherapy for NAS (time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03762317.

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 Feb 2023.