Seizures
Conditions
Keywords
seizures, neonate, levetiracetam, Epilepsy, central nervous system diseases, anticonvulsants
Brief summary
The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.
Interventions
DRUGlevetiracetam
50 mg/kg single loading dose of IV levetiracetam
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
Inclusion criteria
* Gestational age ≥ 32 weeks * Postnatal age ≤ 30 days * Birth weight ≥ 2000 grams * Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital * Clinical or electrographic seizures of any etiology * Seizures or seizure prophylaxis requiring treatment with levetiracetam * Parental consent obtained
Exclusion criteria
* Infants with renal insufficiency indicated by serum creatinine \> 2.0 at any time * Infants who have previously received levetiracetam * Parents refuse consent * Attending physician does not wish the infant to be enrolled in the study * Infants who are currently receiving an investigational drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Profile | 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses) | 3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm. |
Countries
United States
Participant flow
Recruitment details
Recruitment was from 9/2010 to 8/2011 from the NICU at Cincinnati Children's Hospital.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm, 50 mg/kg of Levetiracetam Single arm, 50 mg/kg of levetiracetam | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Single Arm, 50 mg/kg of Levetiracetam |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Pharmacokinetic Profile
3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.
Time frame: 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)
Population: all participants had adequate levels drawn for analysis
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Single Arm, 50 mg/kg of Levetiracetam | Pharmacokinetic Profile | 0.51 ml/min/kg | Full Range 0 |