Chorioamnionitis, Early Onset Neonatal Sepsis, Sepsis of the Newborn
Conditions
Keywords
Chorioamnionitis, Early onset neonatal sepsis, Antibiotics, Clinical observation
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.
Interventions
OTHERClinical observation
Antibiotics will be started only if sepsis-related signs or symptoms are present.Clinical observation consists in a standardized physical examination protocol according to which newborns are observed by the nurses at 1, 2, 4, 8, 12, 16, 20, 24 hours of life and then every 6 hours up to 48 hours of life. The following signs and symptoms are checked: skin colour (pink/pale/cyanotic/mottled), respiratory rate (lower or higher than 60 breaths/minute) and presence or absence of respiratory distress.
OTHERStandard management
Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol
Sponsors
IRCCS Burlo Garofolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Minutes to 6 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sepsis-related signs and symptoms | 48 hours of life | Presence of pale/cyanotic/mottled skin, respiratory rate higher than 60 breaths/minute or respiratory distress |
Secondary
| Measure | Time frame |
|---|---|
| Mortality | 21 days |
| Neonatal intensive care unit admittance | 21 days |
| Days of antibiotics | 21 days |
| Days of hospitalization | 21 days |
Countries
Italy
Outcome results
None listed