Prophylactic Phenobarbital After Neonatal Seizures (PROPHENO)
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|ClinicalTrials.gov Identifier: NCT01089504|
Recruitment Status : Terminated (Inadequate rate of enrollment)
First Posted : March 18, 2010
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Seizures||Drug: phenobarbital Drug: placebo||Phase 4|
The treatment of infants with antiepileptic medications after the resolution of neonatal seizures is highly variable and controversial. Infants are commonly treated with phenobarbital after their seizures have resolved to prevent recurrence. Data to support this practice are lacking but animal models suggest that the neonatal brain is vulnerable to repeated seizures. Yet exposure of the developing brain to phenobarbital for prolonged periods may have deleterious consequences. We are proposing a multi-center, randomized, clinical trial (RCT) to determine if continued treatment with phenobarbital reduces seizure recurrence without adversely affecting neurodevelopmental outcome or if infants' outcomes are improved if no prophylactic medication is given. We will identify infants with seizures beginning in the first week that resolve within 7 days and randomize them to receive phenobarbital or placebo daily for four months. Via visits and frequent telephone contacts over the first six months, we will determine the rate of seizure recurrence. The primary outcome, neurodevelopmental status, will be assessed at 18-22 months using the Bayley Scales of Infant Development. Additional subgroup analyses are planned to determine the contribution of seizure etiology to outcome and predictive value of initial EEG classification. The trial will be conducted at 18 - 20 sites, chosen for their experience and proven track record for enrollment and retention in this specific population. The trial will be coordinated by the Clinical Trials Coordination Center at the University of Rochester and overseen by a Steering Committee composed of experienced trialists representing neonatology and pediatric neurology, biostatistics, and clinical trial administration.
Extrapolation from the results of an RCT of phenobarbital prophylaxis after febrile seizures in children suggests that phenobarbital may adversely affect brain development and may be ineffective in preventing seizures. Based on this previous RCT that resulted in near universal change in practice (the elimination of prolonged use of phenobarbital after simple febrile seizures), we anticipate that the data we generate may have a similar impact on standard of care for infants with neonatal seizures.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prophylactic Phenobarbital After Resolution of Neonatal Seizures|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: Phenobarbital
Phenobarbital, 4-5 mg/kg/day, for 4 months
Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
Placebo Comparator: Placebo
Placebo in a volume equivalent to active drug for 4 months
Matched placebo, same volume as active drug, by mouth daily for 4 months
- Mean Bayley Scales of Infant Development (BSID) Score - Cognitive [ Time Frame: 18-22 months ]The Bayley Scales of Infant Development (BSID) measure the mental and motor development and test the behavior of infants from one to 42 months of age. The test is intended to measure a child's level of development in three domains: cognitive, motor, and behavioral. The primary outcome is the Bayley assessment of development at 2 years of age. This is a standardized developmental exam that is normalized to the age of the child in months. The mean adjusted score is 100 with a standard deviation of 15 (higher being better) - very similar to the more familiar IQ score.
- Mean Bayley Scales of Infant Development (BSID) Score - Motor [ Time Frame: 18-22 months ]This part of the BSID assesses the degree of body control, large muscle coordination, finer manipulatory skills of the hands and fingers, dynamic movement, postural imitation, and the ability to recognize objects by sense of touch.
- Number of Participants With One or More Seizures [ Time Frame: 18-22 months ]Any clinical or electrographic seizures occurring between study entry and all follow-up examinations and contacts.
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): NCT01089504
|Principal Investigator:||Ronnie Guillet, MD, PhD||University of Rochester|