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

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ClinicalTrials.gov Identifier: NCT02886910
Recruitment Status : Withdrawn
First Posted : September 1, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Luca Ronfani, 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.

Condition or disease Intervention/treatment Phase
Chorioamnionitis Early Onset Neonatal Sepsis Sepsis of the Newborn Other: Clinical observation Other: Standard management Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Chorioamnionitis: Observation of at Risk Infants vs Standard Care. Randomized Controlled Trial.
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 21 days ]
  2. Neonatal intensive care unit admittance [ Time Frame: 21 days ]
  3. Days of antibiotics [ Time Frame: 21 days ]
  4. Days of hospitalization [ Time Frame: 21 days ]


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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886910


Locations
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Italy
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
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Study Director: Sergio Demarini, MD Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy

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Responsible Party: Luca Ronfani, MD, PhD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT02886910     History of Changes
Other Study ID Numbers: RC 18/14
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luca Ronfani, IRCCS Burlo Garofolo:
Chorioamnionitis
Early onset neonatal sepsis
Antibiotics
Clinical observation
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Sepsis
Toxemia
Neonatal Sepsis
Chorioamnionitis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases