Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Status:
Terminated
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very
low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the
proinflammatory state caused by infection that puts them at risk for Bronchopulmonary
Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age)
treatment with intravenous azithromycin versus expectant management for VLBW infants with
Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine
microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for
eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of
infants in the two treatment groups and those without respiratory tract Ureaplasma spp.
infection