Chorioamnionitis: Observation of at Risk Infants vs Standard Care

Chorioamnionitis Clinical Trial

— CHORIS-RCT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02886910
• Other study ID #: RC 18/14
• Status: Withdrawn
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 2019

Study information

• Verified date: July 2019
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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

Related Conditions & MeSH terms

• Chorioamnionitis
• Early Onset Neonatal Sepsis
• Neonatal Sepsis
• Sepsis
• Sepsis of the Newborn
• Toxemia

Intervention

Other:
• Clinical observation
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.
• Standard management
Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality		21 days
Secondary	Neonatal intensive care unit admittance		21 days
Secondary	Days of antibiotics		21 days
Secondary	Days of hospitalization		21 days