Clinical Trial: Chorioamnionitis: Observation of at Risk Infants vs Standard Care

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: IRCCS Burlo Garofolo

Current Primary Outcome: Sepsis-related signs and symptoms [ Time Frame: 48 hours of life ]

Presence of pale/cyanotic/mottled skin, respiratory rate higher than 60 breaths/minute or respiratory distress


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality [ Time Frame: 21 days ]
  • Neonatal intensive care unit admittance [ Time Frame: 21 days ]
  • Days of antibiotics [ Time Frame: 21 days ]
  • Days of hospitalization [ Time Frame: 21 days ]


Original Secondary Outcome: Same as current

Information By: IRCCS Burlo Garofolo

Dates:
Date Received: August 29, 2016
Date Started: October 2016
Date Completion: November 2019
Last Updated: August 29, 2016
Last Verified: August 2016