Chorioamnionitis: Observation of at Risk Infants vs Standard Care

NCT ID: NCT02886910

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-11-30

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.

Conditions

Chorioamnionitis; Early Onset Neonatal Sepsis; Sepsis of the Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Clinical observation

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Clinical observation

Intervention Type: OTHER

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

Intervention Type: OTHER

Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol

Interventions

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.

Intervention Type: OTHER

Standard management

Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 10 Minutes
• Maximum Eligible Age: 6 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Luca Ronfani

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio Demarini, MD

Role: STUDY_DIRECTOR

Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy

Locations

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, Italy

Countries

Italy

Other Identifiers

RC 18/14

Identifier Type: -

Identifier Source: org_study_id