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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chorioamnionitis; Sepsis of the Newborn; Early Onset Neonatal Sepsis
• Intervention / Treatment: Other: Clinical observation; Other: Standard management

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Friuli Venezia Giulia
    • Trieste, Friuli Venezia Giulia, Italy, 34137
      • Institute for Maternal and Child Health IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Sergio Demarini, MD, Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Chorioamnionitis; Antibiotics; Early onset neonatal sepsis; Clinical observation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Fetal Diseases; Pregnancy Complications; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Sepsis; Toxemia; Chorioamnionitis; Neonatal Sepsis
• Other Study ID Numbers: RC 18/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No