Chorioamnionitis: Observation of at Risk Infants vs Standard Care (CHORIS-RCT)

IRCCS Burlo Garofolo

Status: Withdrawn

Conditions: Chorioamnionitis; Sepsis of the Newborn; Early Onset Neonatal Sepsis

Treatments: Other: Clinical observation; Other: Standard management

Study type: Interventional

Funder types: Other

Identifiers

NCT02886910

RC 18/14

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 10 minutes to 6 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Clinical observation

Experimental group

Description:

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.

Treatment:

Other: Clinical observation

Standard management

Active Comparator group

Description:

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.

Treatment:

Other: Standard management

Other: Clinical observation