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Prophylactic Phenobarbital After Neonatal Seizures

Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Seizures

Intervention: phenobarbital (Drug); placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Ronnie Guillet, MD, PhD, Principal Investigator, Affiliation: University of Rochester

Summary

The treatment of infants with medications after their seizures have stopped is very variable. No one knows if continuing treatment with phenobarbital for up to several months is helpful or harmful. This clinical trial is designed to help answer that question and provide data that will help determine standard of care for these children.

Clinical Details

Official title: Prophylactic Phenobarbital After Resolution of Neonatal Seizures

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Bayley Scales of Infant Development

Secondary outcome:

Bayley Scales of Infant Development - Motor

Seizure recurrence

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: 2 Weeks. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Birth at > 34 weeks' gestation

- Neonatal seizures (clinical, electrographic or both), with onset in the first 120

hours after birth and resolution within 7 days of onset

- Parental informed consent

Exclusion Criteria:

- Birth at < 34 weeks' gestation

- If the attending neonatologist attributes the seizures solely to a transient

abnormality, easily correctable and unlikely to recur (eg, transient electrolyte abnormalities). If the attending neonatologist cannot be contacted, the site PI will be asked to review the available information and judge whether the infant is eligible.

- If the infant has been diagnosed with or there is a strong suspicion of an inborn

error of metabolism, significant brain malformation, microcephaly (< 3 %ile), or a chromosomal abnormality which, in the absence of seizures, is known to be independently associated with an increased likelihood of cognitive impairment

- If the infant has been diagnosed with an intrauterine viral infection

- If the infant is not expected to survive to discharge

Locations and Contacts

University of Arkansas, Little Rock, Arkansas 72202, United States

University of California San Francisco, San Francisco, California 94143, United States

Univeristy of Iowa, Iowa City, Iowa 52242, United States

Johns Hopkins University, Baltimore, Maryland 21224, United States

Tufts Medical Center, Boston, Massachusetts 02111, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

Women & Children's Hospital of Buffalo, Buffalo, New York 14222, United States

University of Rochester, Rochester, New York 14642, United States

Forsyth Medical Center, Winston Salem, North Carolina 27157, United States

Wake Forest University, Winston Salem, North Carolina 27157, United States

Akron Children's Hospital, Akron, Ohio 44308, United States

Nationwide Children's Hospital, Columbus, Ohio 43205, United States

Magee Womens Hospital, Pittsburgh, Pennsylvania 15224, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15224, United States

Women & Infants Hospital of Rhode Island, Providence, Rhode Island 02905, United States

Primary Children's Medical Center, Salt Lake City, Utah 84108, United States

University of Utah, Salt Lake City, Utah 84108, United States

University of Virginia, Charlottesville, Virginia 22908, United States

Additional Information

Starting date: September 2010
Last updated: February 18, 2015

Page last updated: August 23, 2015

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