ChorioamnionitisCHORIS-RCTNCT02886910
Chorioamnionitis: Observation of at Risk Infants vs Standard Care
A study testing Clinical observation and Standard management in people with Chorioamnionitis and Early Onset Neonatal Sepsis, run by IRCCS Burlo Garofolo at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 10 minutes to 6 hours
- Conditions the study is for
- Chorioamnionitis, Early Onset Neonatal Sepsis, Sepsis of the Newborn
- What is being tested?
- Clinical observation and Standard management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2016to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- asymptomatic newborns born at term (>= 37 weeks of gestational age)
Who cannot join
- preterm newborns (< 37 weeks gestational age)
- sepsis-related signs of symptoms at birth
- intensive care admittance
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, 34137
About this study
Official title: 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.
Read the 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.
- Being tested
- Clinical observation, Standard management
- Keywords
- Chorioamnionitis, Early onset neonatal sepsis, Antibiotics, Clinical observation
- Medical subject headings
- Chorioamnionitis, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical observationOther
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 managementOther
Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol
| Study group | Role | What they receive |
|---|---|---|
| Clinical observation | Experimental | 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. Receives: Other: Clinical observation |
| Standard management | Active comparator | 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. Receives: Other: Clinical observation; Other: Standard management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis-related signs and symptoms
Presence of pale/cyanotic/mottled skin, respiratory rate higher than 60 breaths/minute or respiratory distress
Measured: 48 hours of life
Secondary outcomes (4)
Mortality
Measured: 21 days
Neonatal intensive care unit admittance
Measured: 21 days
Days of antibiotics
Measured: 21 days
Days of hospitalization
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChorioamnionitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ronfani, IRCCS Burlo Garofolo
- Investigators
- Sergio Demarini, MD, Study director, Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886910
- Sponsor's protocol ID
- RC 18/14
- Acronym
- CHORIS-RCT
- Status last verified
- Jul 2019
- First submitted
- 29 Aug 2016
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chorioamnionitis: Observation of at Risk Infants vs Standard Care. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02886910
- Acronym / sponsor ID
- CHORIS-RCT / RC 18/14
- Keywords
- Chorioamnionitis, Early onset neonatal sepsis, Antibiotics, Clinical observation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical observation | Experimental | Other: Clinical observationAsymptomatic 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. |
| Standard management | Active comparator | Other: Clinical observation, Other: Standard managementAsymptomatic 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. |
Who may qualify
- Ages
- 10 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- asymptomatic newborns born at term (>= 37 weeks of gestational age)
Key exclusion criteria (3 listed)
- preterm newborns (< 37 weeks gestational age)
- sepsis-related signs of symptoms at birth
- intensive care admittance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical observationAntibiotics 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 | Clinical observation, Standard management |
| Standard managementAntibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol | Other | Standard management |
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
4 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Demarini, MD study director
Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical observation and Standard management in people with Chorioamnionitis and Early Onset Neonatal Sepsis, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sepsis-related signs and symptoms (time frame: 48 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.