Clonidine for Neonatal Abstinence Syndrome Study
Information source: Baystate Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neonatal Abstinence Syndrome
Intervention: Clonidine (Drug); Phenobarbital (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Baystate Medical Center Official(s) and/or principal investigator(s):
Rachana Singh, MD, MS, Principal Investigator, Affiliation: Baystate Medical Center
Summary
The study plans to compare the use of Clonidine versus Phenobarbital as an additional
medication to neonatal morphine sulfate for treatment of newborn infants undergoing drug
withdrawal symptoms due to mother's use of opioid drug use. The investigators hypothesis is
that use of Clonidine will lead to shorter duration of treatment, hospital stay and thereby
early discharge home.
Clinical Details
Official title: Comparison of Clonidine Versus Phenobarbital as an Adjunct Therapy for Neonatal Abstinence Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Length of Treatment With Neonatal Morphine Sulfate
Secondary outcome: Total Dose of NMS Used
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: 15 Days.
Gender(s): Both.
Criteria:
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
-
Locations and Contacts
NICU @ Baystate Children's Hospital, Springfield, Massachusetts 01199, United States
Additional Information
Starting date: July 2010
Last updated: November 18, 2013
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