Prophylactic Phenobarbital After Neonatal Seizures

NCT01089504 | Terminated Phase 4 Results DMC

• 1 other identifier: 28907
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Neonatal Seizures

Keywords

phenobarbital; neonate; antiepileptic drugs; neurodevelopmental outcome; seizure

Outcome Measures

Primary Outcomes (1)

• Mean Bayley Scales of Infant Development (BSID) Score - Cognitive

  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.

  18-22 months

Secondary Outcomes (2)

• Mean Bayley Scales of Infant Development (BSID) Score - Motor

  18-22 months

• Number of Participants With One or More Seizures

  18-22 months

Study Arms (2)

Phenobarbital

ACTIVE COMPARATOR

Phenobarbital, 4-5 mg/kg/day, for 4 months

Drug: phenobarbital

Placebo

PLACEBO COMPARATOR

Placebo in a volume equivalent to active drug for 4 months

Drug: placebo

Interventions

phenobarbital DRUG

Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months

Phenobarbital

placebo DRUG

Matched placebo, same volume as active drug, by mouth daily for 4 months

Placebo

Eligibility Criteria

• Age: 2 Days - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (18)

University of Arkansas

Little Rock, Arkansas, 72202, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Univeristy of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Women & Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84108, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Seizures

Interventions

Phenobarbital

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary analysis.

Results Point of Contact

• Title: Ronnie Guillet
• Organization: University of Rochester

ronnie_guillet@urmc.rochester.edu

585-275-6209

Study Officials

• Ronnie Guillet, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 3, 2016
• Results First Posted: February 3, 2016

Record last verified: 2016-01

Locations

US (18)