Metronidazole Pharmacokinetics (PK) in Premature Infants
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Michael Cohen-Wolkowiez
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) The Emmes Company, LLC The EMMES Corporation