Chorioamnionitis Clinical Trial
Official title:
Chorioamnionitis: Observation of at Risk Infants vs Standard Care. Randomized Controlled Trial.
This study evaluates the non-inferiority of a protocol of limited evaluation (complete blood count, blood culture) and clinical observation by standardized physical examination versus the algorithm suggested in the CDC's 2010 guidelines (limited evaluation, clinical observation and antibiotic therapy) in the management of asymptomatic infants born at term to mothers with suspected chorioamnionitis. The primary outcome of the study is the difference in the prevalence of sepsis-related symptoms between the two groups.
Chorioamnionitis complicates 1-3% of pregnancies at term. The current international
guidelines of the Center for Disease Control (CDC 2010) recommend that all asymptomatic
newborns born to mothers with suspected chorioamnionitis undergo limited evaluation (i.e.
blood culture at birth and complete blood count) and antibiotic therapy until the blood
culture result is available.
However, the prevalence of positive blood cultures in infants born to mothers with suspected
chorioamnionitis is low, approximately 1%, including also infants requiring intensive care.
This prevalence is even lower in asymptomatic infants. Moreover, the efficacy of antibiotic
prophylaxis in preventing early sepsis, death or long-term sequelae in asymptomatic infants
born to mothers with suspected chorioamnionitis has not been demonstrated.
Early antibiotic use has been related to obesity and to the modification of microbiota.
Limiting antibiotic use may prevent the emergence of antibiotic-resistant bacteria.
Clinical observation is a reliable method to recognize infants with sepsis.
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