Chorioamnionitis: Observation of at Risk Infants vs Standard Care. Randomized Controlled Trial.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chorioamnionitis
- Sponsor
- IRCCS Burlo Garofolo
- Locations
- 1
- Primary Endpoint
- Sepsis-related signs and symptoms
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Luca Ronfani
MD, PhD
IRCCS Burlo Garofolo
Eligibility Criteria
Inclusion Criteria
- •asymptomatic newborns born at term (\>= 37 weeks of gestational age)
Exclusion Criteria
- •preterm newborns (\< 37 weeks gestational age)
- •sepsis-related signs of symptoms at birth
- •intensive care admittance
Outcomes
Primary Outcomes
Sepsis-related signs and symptoms
Time Frame: 48 hours of life
Presence of pale/cyanotic/mottled skin, respiratory rate higher than 60 breaths/minute or respiratory distress
Secondary Outcomes
- Mortality(21 days)
- Neonatal intensive care unit admittance(21 days)
- Days of antibiotics(21 days)
- Days of hospitalization(21 days)