Clonidine for Neonatal Abstinence Syndrome Study
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| ClinicalTrials.gov Identifier: NCT01175668 |
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Recruitment Status :
Terminated
(Based on the planned interim analysis results at 50% recruitment, after IRB reviewed the results, further enrollment was stopped.)
First Posted : August 5, 2010
Results First Posted : January 6, 2014
Last Update Posted : January 6, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neonatal Abstinence Syndrome | Drug: Clonidine Drug: Phenobarbital | Not Applicable |
Introduction: Neonatal abstinence syndrome (NAS) is a symptom complex experienced by 55 to 94% of neonates who are exposed to intrauterine opioids. Recent studies have shown that combination therapies are superior to monotherapy with neonatal morphine sulfate (NMS). Phenobarbital has been shown to reduce the length of hospitalization, decrease severity of withdrawal, as well as decrease hospital costs and care giver demands. Similarly, clonidine, an α2-adrenergic receptor agonist, has also been shown to be safe, effective and reduces length of treatment.
Phenobarbital as an antiepileptic acts on the GABA (A) receptors and has been shown in animal models to inhibit neuronal cell proliferation, survival and neurogenesis. In human infants long term treatment with phenobarbital may result in neuro-developmental compromise. Due to these potentially harmful effects of Phenobarbital (P) alternative therapies should be explored more thoroughly including clonidine (C).
Our primary aim is to compare the length of NAS treatment with NMS in the two study groups - NMS/C versus NMS/P. Our secondary aims are to compare the total dosage of NMS, total length of hospital stay for NAS treatment, treatment failures and adverse effect profiles for the two study groups. We hypothesize that clonidine when compared to phenobarbital as an adjunct therapy, will have shorter length of stay, with fewer treatment failures and side effects.
Study design/Methods: This study will be a prospective, randomized, non-blinded clinical trial of NMS/C versus NMS/P for treatment of infants with NAS. Infants will be recruited from the Baystate Children's Hospital Neonatal Intensive Care Unit (NICU) and Neonatal Continuing Care Nursery (NCCN), a level III unit, over a 2 year study period. After randomization, infants will adhere to strict treatment initiation and withdrawal protocols. Maternal and infant descriptive data will be collected along with specific data regarding vital signs, drug dosages, length of treatment, treatment failures and adverse effects.
The primary outcome will be length of treatment with NMS in the two study arms. The secondary outcomes will be - a) total length of hospital stay for NAS treatment, b) mean total treatment dose and mean daily dose of NMS, c) total number of treatment failures,d) adverse effects such as bradycardia, hypotension, hypertension e) Total outpatient therapy days with Phenobarbital
Significance: This comparison study is potentially of great significance. If clonidine is proven to be equally effective in treatment of NAS many of the detrimental effects of phenobarbital therapy may be avoided for infants on long term pharmacotherapy for treatment of withdrawal with shorter length of hospital stay.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 68 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of Clonidine Versus Phenobarbital as an Adjunct Therapy for Neonatal Abstinence Syndrome |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | August 2012 |
| Actual Study Completion Date : | October 2012 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: NMS/Clonidine |
Drug: Clonidine
This group of infants undergoing NAS will be treated with neonatal morphine sulfate and Clonidine as an adjunct medication to control the symptoms. Once stable Finnegan scores <8 for 24h, NMS will be weaned by 10% daily till off, then Clonidine will be weaned off in a stepwise manner. Infant will not go home on any medication for NAS. NMS will be dosed as mg/kd/day divided q3h and Clonidine will be dosed as microgm/kg/day divided q6h based upon the initial Finnegan scores. |
| Active Comparator: NMS/Phenobarbital |
Drug: Phenobarbital
Infants in this arm will be treated as current standard practice with NMS and Phenobarbital. NMS will be weaned by 10% daily to completely off during the hospital stay. Infants will be discharged home on Phenobarbital. NMS will be dosed as mg/kg/day divided q3h and Phenobarbital will be dosed as mg/kg/day divided q8h based on the Finnegan scores. |
- Length of Treatment With Neonatal Morphine Sulfate [ Time Frame: subjects were followed for the duration of treatment, up to 3 months ]
- Total Dose of NMS Used [ Time Frame: For the duration of treatment, upto 3 months ]
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| Ages Eligible for Study: | up to 15 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 0 to 15 days of age
- Prenatal exposure to opioids with development of moderate to severe NAS (2 consecutive abstinence scores of ≥ 8)
- Medically stable
Exclusion Criteria:
- Gestational age < 35 weeks
- Intrauterine growth retardation (birth weight below the 5th percentile)
- Congenital heart disease
- Congenital anomalies
- Medically unstable
Exposure to Benzodiazepines prenatally
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175668
| United States, Massachusetts | |
| NICU @ Baystate Children's Hospital | |
| Springfield, Massachusetts, United States, 01199 | |
| Principal Investigator: | Rachana Singh, MD, MS | Baystate Medical Center |
| Responsible Party: | Rachana Singh, MD, Assistant Professor of Pediatrics, Baystate Medical Center |
| ClinicalTrials.gov Identifier: | NCT01175668 |
| Other Study ID Numbers: |
BH-10-196 |
| First Posted: | August 5, 2010 Key Record Dates |
| Results First Posted: | January 6, 2014 |
| Last Update Posted: | January 6, 2014 |
| Last Verified: | November 2013 |
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Neonatal Abstinence Syndrome Syndrome Disease Pathologic Processes Infant, Newborn, Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Clonidine Phenobarbital Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antihypertensive Agents |
Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anticonvulsants Hypnotics and Sedatives Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents GABA Modulators GABA Agents |