Chorioamnionitis: Observation of at Risk Infants vs Standard Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Chorioamnionitis: Observation of at Risk Infants vs Standard Care. Randomized Controlled Trial.

Conditions
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Chorioamnionitis, Early Onset Neonatal Sepsis, Sepsis of the Newborn

Intervention / Treatment
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* Other: Clinical observation
* Other: Standard management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Minutes
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical observation<br>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<br>* 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.<br>|
| Active Comparator: Standard management<br>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<br>* 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.<br>Other: Standard management<br>* Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis-related signs and symptoms | Presence of pale/cyanotic/mottled skin, respiratory rate higher than 60 breaths/minute or respiratory distress | 48 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 21 days | 
| Neonatal intensive care unit admittance |  | 21 days | 
| Days of antibiotics |  | 21 days | 
| Days of hospitalization |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chorioamnionitis, Early onset neonatal sepsis, Antibiotics, Clinical observation