Clinical trial NCT02886910: Chorioamnionitis: Observation of at Risk Infants vs Standard Care
Official title: Chorioamnionitis: Observation of at Risk Infants vs Standard Care. Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chorioamnionitis
Early Onset Neonatal Sepsis
Sepsis of the Newborn
Keywords: Chorioamnionitis
Early onset neonatal sepsis
Antibiotics
Clinical observation
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Sepsis-related signs and symptoms
timeFrame: 48 hours of life
Secondary outcomes:
measure: Mortality
timeFrame: 21 days
measure: Neonatal intensive care unit admittance
timeFrame: 21 days
measure: Days of antibiotics
timeFrame: 21 days
measure: Days of hospitalization
timeFrame: 21 days
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
Study officials:
affiliation: Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
name: Sergio Demarini, MD
role: STUDY_DIRECTOR
References: