Chorioamnionitis: Observation of at Risk Infants vs Standard Care

Not Applicable

Withdrawn

• Conditions: Chorioamnionitis; Early Onset Neonatal Sepsis; Sepsis of the Newborn
• Interventions: Other: Clinical observation; Other: Standard management

• Registration Number: NCT02886910
• Lead Sponsor: IRCCS Burlo Garofolo

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.

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-01
• Study Start: 2016-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-12
• Primary Completion: 2019-10
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard management	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.
Clinical observation	Clinical observation	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.
Standard management	Standard management	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mortality	21 days
Neonatal intensive care unit admittance	21 days
Days of antibiotics	21 days
Days of hospitalization	21 days

Trial Locations

Locations (1)

Institute for Maternal and Child Health IRCCS Burlo Garofolo; 🇮🇹 Trieste, Friuli Venezia Giulia, Italy