Clinical Trial: Clonidine for Neonatal Abstinence Syndrome Study
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Comparison of Clonidine Versus Phenobarbital as an Adjunct Therapy for Neonatal Abstinence Syndrome
Brief 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.
Detailed Summary:
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,
Sponsor: Baystate Medical Center
Current Primary Outcome: Length of Treatment With Neonatal Morphine Sulfate [ Time Frame: subjects were followed for the duration of treatment, up to 3 months ]
Original Primary Outcome: Length of treatment [ Time Frame: During hospital stay which on an average is 25 days ]
Current Secondary Outcome: Total Dose of NMS Used [ Time Frame: For the duration of treatment, upto 3 months ]
Original Secondary Outcome: NBAS scores [ Time Frame: After 1-2 days of initiating therapy then at 5-7 days after starting therapy ]
Information By: Baystate Medical Center
Dates:
Date Received: July 14, 2010
Date Started: July 2010
Date Completion:
Last Updated: November 18, 2013
Last Verified: November 2013
