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Alpha-2 Adrenergic Agonist

Clonidine vs Morphine for Neonatal Abstinence Syndrome

Phase 4
Recruiting
Led By Alla Kushnir, MD
Research Sponsored by The Cooper Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No congenital anomalies or neurologic condition (i.e. hypoxic-ischemic encephalopathy, seizures, meningitis etc.)
Greater than or equal to 35 weeks gestation age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 18-24 months corrected gestational age
Awards & highlights

Study Summary

This trial will compare the effects of Clonidine to those of Morphine in Neonatal Abstinence Syndrome.

Who is the study for?
This trial is for newborns born at Cooper University Hospital, who are at least 35 weeks gestational age and show withdrawal symptoms from substances their mothers used during pregnancy. These babies should not have congenital anomalies or major medical conditions like blood pressure instability.Check my eligibility
What is being tested?
The study compares Clonidine with Morphine Sulfate to see if Clonidine can shorten the hospital stay and treatment duration for Neonatal Abstinence Syndrome (NAS), which affects babies withdrawing from exposure to drugs in the womb.See study design
What are the potential side effects?
Clonidine may cause low blood pressure, slow heart rate, drowsiness, or dry mouth. Morphine's side effects include respiratory depression, constipation, sedation, and potential dependency issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any birth defects or brain conditions.
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I am at least 35 weeks into my pregnancy.
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My baby is in the NICU or Transitional nursery.
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My baby is starting medication for withdrawal symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 18-24 months corrected gestational age
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18-24 months corrected gestational age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Length of stay
Secondary outcome measures
Length of treatment
Other outcome measures
Cognitive development

Side effects data

From 2009 Phase 4 trial • 12 Patients • NCT00370838
50%
Tired/sleepy
40%
Anxious
30%
Fatigue
30%
Aggression
20%
Stomache ache
20%
Lethargic
20%
Insomnia
20%
Irritability
10%
Dry mouth
10%
Dizzy
10%
Sleepwalking
10%
Sad/depressed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clonidine
Levetiracetam

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ClonidineExperimental Treatment1 Intervention
Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours
Group II: MorphineActive Control1 Intervention
Morphine Sulfate at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clonidine
2010
Completed Phase 4
~1890

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor
76 Previous Clinical Trials
33,023 Total Patients Enrolled
Alla Kushnir, MD5.01 ReviewsPrincipal Investigator - The Cooper Health System
The Cooper Health System
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Clonidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03092011 — Phase 4
Neonatal Abstinence Syndrome Research Study Groups: Clonidine, Morphine
Neonatal Abstinence Syndrome Clinical Trial 2023: Clonidine Highlights & Side Effects. Trial Name: NCT03092011 — Phase 4
Clonidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03092011 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still recruitment opportunities for participants in this experiment?

"Correct. Clinicaltrials.gov's data shows that the trial, first posted on February 21st 2018 and last modified on March 7th 2022, is currently seeking participants with 90 patients being recruited from a single medical facility."

Answered by AI

What medical ailments can Clonidine be prescribed to treat?

"Clonidine is a well-studied medication for addressing diabetic diarrhea, as well as other health issues such as pheochromocytoma, attention deficit hyperactivity disorder (ADHD), and menopause."

Answered by AI

To what extent is the participant pool for this experiment populated?

"Affirmative, the information on clinicaltrials.gov states that this trial is currently recruiting participants. The initial post date was February 21st 2018 and it has most recently been updated on March 7th 2022. This medical research requires 90 participants at a single location."

Answered by AI

Could you outline the other exploratory experiments that have been done with Clonidine?

"Currently, 71 medical studies are being conducted with Clonidine as the primary intervention. 20 of those trials are in Phase 3 and 201 different sites across the country will be involved. Boston, Massachusetts is among them."

Answered by AI

Has Clonidine been granted permission to be used by the FDA?

"There is a wealth of evidence in support of Clonidine's safety, so it received an impressive score of 3 on our scale. This assessment was made possible because this medication has already been approved as part of its Phase 4 trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
Alla Kushnir 2018. "Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03092011.
~8 spots leftby Dec 2024
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