Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk of mental retardation. Metronidazole is an antibiotic that is often administered to infants with suspected or confirmed necrotizing enterocolitis. Unfortunately, the appropriate dose of metronidazole in premature infants has not been established and it is likely to be different from older children and adults. The investigators will investigate the appropriate metronidazole dose in very premature infants by: 1) determining how premature infants eliminate metronidazole from the body and 2) determining the safest and most effective dose of metronidazole in premature infants. The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary drug levels to treat bacteria involved in necrotizing enterocolitis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Metronidazole will be administered intravenously to premature infants as a 15 mg/kg loading dose followed by maintenance doses of 7.5 mg/kg every 12 hours for infants with \>=14 postnatal days and every 24 hours for infants \<14 postnatal days.
CHOC Children's
Orange, California, United States
Wesely Medical Center
Wichita, Kansas, United States
Duke University
Durham, North Carolina, United States
Area Under the Curve at Steady State
Area under the curve at steady state (AUCss)
Time frame: pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose
Loading Dose Maximum Concentration
Loading Dose Maximum concentration (Cmax)
Time frame: 2-5 days of study drug administration
Loading Dose Minimum Concentration
Loading Dose Minimum Concentration (mg/L)
Time frame: 2-5 days of study drug administration
Multiple Dose Maximum Concentration
Multiple Dose Maximum Concentration (mg/L)
Time frame: 2-5 days of study drug administration
Multiple Dose Minimum Concentration
Multiple Dose Minimum Concentration (mg/L)
Time frame: 2-5 days of study drug administration
Clearance
Clearance (L/h/kg)
Time frame: 2-5 days of study drug administration
Volume of Distribution
Volume of Distribution (L/kg)
Time frame: 2-5 days of study drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.