Prophylactic Phenobarbital After Neonatal Seizures

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Neonatal Seizures

In brief

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.

Key facts

Study ID

NCT01089504

Run by

University of Rochester

People needed

13

Starts

2010-09-01

Expected to finish

2014-11-01

Last updated by the study team

2016-02-03

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States
• University of California San Francisco — San Francisco, California, United States
• Univeristy of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Women & Children's Hospital of Buffalo — Buffalo, New York, United States
• University of Rochester — Rochester, New York, United States
• Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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