An interventional study of Clinical observation and Standard management in Chorioamnionitis, Early Onset Neonatal Sepsis and Sepsis of the Newborn, sponsored by IRCCS Burlo Garofolo. Withdrawn at 1 site in Italy. Open to participants aged 10 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2019-07-12.
Sponsored by IRCCS Burlo Garofolo · Not applicable, Interventional, and Prevention
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.
39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.
Browse Chorioamnionitis studies →IRCCS Burlo Garofolo is the lead sponsor of 89 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Asymptomatic newborns born at term to mothers with suspected chorioamnionitis. They will receive a limited evaluation (blood culture, complete blood count), and a clinical observation. Antibiotics will be started only if sepsis-related signs or symptoms are present.
Other: Clinical observation
Asymptomatic newborns born at term to mothers with suspected chorioamnionitis. The will receive a limited evaluation (blood culture, complete blood count), a clinical observation and antibiotics at birth.
Other: Clinical observation · Other: Standard management
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.
Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol
Sepsis-related signs and symptoms
Presence of pale/cyanotic/mottled skin, respiratory rate higher than 60 breaths/minute or respiratory distress
Time frame: 48 hours of life
Mortality
Time frame: 21 days
Neonatal intensive care unit admittance
Time frame: 21 days
Days of antibiotics
Time frame: 21 days
Days of hospitalization
Time frame: 21 days
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2016 (actual). Primary completion is estimated for Oct 2019, 36 months after the start.
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This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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IRCCS Burlo Garofolo