Infant, Newborn, DiseasesEOSIINCT02410486
Early-Onset Sepsis an NICHD/CDC Surveillance Study
An observational study of Infant, Newborn, Diseases and Early Onset Neonatal Sepsis, run by NICHD Neonatal Research Network at 20 sites in United States.
Trial summary
This prospective surveillance study will be conducted over a 2 year period to determine current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated pathogens, antimicrobial resistance, signs and symptoms and infant outcomes. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Infant, Newborn, Diseases, Early Onset Neonatal Sepsis, Early-Onset Meningitis
- How many people
- 570 participants
- Where
- 20 sitesUnited States
- Study dates
- Apr 2015to Dec 2017
- Phase
- Observational
- 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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: The study population will include all live born infants who are at least 22 weeks GA and have a birth weight >400 grams and are delivered at NRN centers.
Who may be able to join
- Case Surveillance: Live born infants with gestational age of at least 22 weeks and birth weight >400 g and <72 hours of age who are delivered at NRN hospitals and have early-onset sepsis and meningitis defined as isolation of a pathogen from blood or CSF obtained within 72 hours of birth and provision of appropriate antibiotic treatment for 5 or more days (or <5 days if death occurs while receiving antibiotic therapy).
- Controls: Live born infants with gestational age of at least 22 weeks and birth weight >400 g who are delivered at NRN hospitals and have not been evaluated for early-onset sepsis (<72 hours of age) or if evaluated, they have sterile blood and/or CSF cultures and were not treated with prolonged antibiotics for clinical "culture negative" sepsis. Controls for infants with Gram-negative infection will be infants without early-onset infection. Controls for infants born to mothers with clinical chorioamnionitis will be infants without early-onset infection born to mothers with clinical chorioamnionitis. Control infants will be born at the same hospital as cases, with the same gestational age grouping as cases (22 0/7 - 28 6/7 weeks; 29 0/7 - 33 6/7 weeks; 34 0/7 - 36 6/7 weeks; and ≥ 37 weeks).
Who cannot join
- Stillbirths and infants who die in the delivery room will be excluded.
- Infants who die within 12 hours of age will be excluded if they have not been evaluated for possible infection-ie, do not have a blood culture obtained to identify EOS.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
RTI International
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of California - Los Angeles
Los Angeles, California, 90025
Stanford University
Palo Alto, California, 94304
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02912
University of Rochester
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84108
About this study
This prospective surveillance study will be conducted over a 2 year period to determine current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated pathogens, antimicrobial resistance, signs and symptoms and infant outcomes.
Read the detailed description
Neonatal pathogens other than group B Streptococcus (GBS) and resistant to beta-lactam antibiotics have emerged as the most common etiologic agents of EOS and EOM among preterm and term neonates and result in high mortality rates, potentially offsetting the decreased burden of early-onset GBS disease prevented by maternal intrapartum chemoprophylaxis.
Primary Outcomes of this study:
- To determine current hospital-based rates of early-onset neonatal infection (total, GA-specific and BW-specific, and pathogen-specific) in term and preterm infants in the era of maternal intrapartum antibiotic prophylaxis to prevent vertical transmission of group B streptococcal disease. Early-onset infection comprises EOS and/or EOM and is defined as isolation of a pathogen from blood or cerebrospinal fluid (CSF) obtained within 72 hours of birth and provision of appropriate antibiotic treatment for 5 or more days (or <5 days if death occurs while receiving antibiotic therapy).
- To determine the antimicrobial susceptibility patterns of organisms associated with EOS and EOM
The case control aspect of this study will address 2 major conundrums regarding EOS: Can we identify risk factors for early-onset Gram-negative infections that might lead to intervention strategies to reduce risk and can we identify infants born to mothers with clinical chorioamnionitis who are at highest risk for early-onset sepsis and thus warrant antibiotic treatment soon after birth?
- Medical subject headings
- Infant, Newborn, Diseases, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EOS infant / mother with chorio | Infant with EOS (Gram-positive or Gram-negative) and mother with Chorioamnionitis | |
| EOS infant / mother without chorio | Infant with EOS (Gram-positive or Gram-negative) and mother without Chorioamnionitis | |
| EOS Gram-neg infant / mother with chorio | Infant with Gram-negative EOS and mother with Chorioamnionitis | |
| Gram-neg infant / mother without chorio | Infant with Gram-negative EOS and mother without Chorioamnionitis | |
| Gram-pos infant / mother with chorio | Infant with Gram-positive EOS and mother with Chorioamnionitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine current hospital-based rates of early-onset neonatal infection
Measured: First 72 hours
To determine the antimicrobial susceptibility patterns of organisms associated with EOS and EOM
Measured: First 72 hours
Secondary outcomes (6)
To identify risk factors associated with EOS/EOM due to Gram-negative pathogens (case control comparison)
Measured: First 72 hours
To determine the clinical signs/symptoms and laboratory abnormalities associated with EOS/EOM
Measured: First 72 hours
To identify risk factors for EOS/EOM in infants born to mothers with chorioamnionitis (case control comparison)
Measured: First 72 hours
To determine if term infants with EOS, identified because of maternal chorioamnionitis, can be asymptomatic at birth
Measured: First 72 hours
To determine sepsis-associated mortality rates (total, GA-specific and BW-specific, pathogen-specific) for infants with EOS/EOM
Measured: First 72 hours
To review changes over time in overall rates of EOS and EOM, pathogens associated with infection, risk factors for infection, clinical and laboratory abnormalities, and sepsis-associated mortality
Measured: 9-11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Newborn, DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Barbara Stoll, MD, Study director, The University of Texas Health Science Center, HoustonMichele Walsh, MD, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's HospitaSeetha Shankaran, MD, Principal investigator, Wayne State UniversityAbbot Laptook, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandMichael Cotten, MD, Principal investigator, Duke UniversityGreg Sokol, MD, Principal investigator, Indiana UniversityAbhik Das, PhD, Principal investigator, RTI InternationalKrisa Van Meurs, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410486
- Sponsor's protocol ID
- NICHD-NRN-0055
- Other IDs
- UG1HD034216, UG1HD027904, UG1HD021364, UG1HD027853, UG1HD040689, UG1HD040492, UG1HD027851, UG1HD087229
- Acronym
- EOSII
- Status last verified
- Mar 2019
- First submitted
- 2 Apr 2015
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kilpatrick R, Greenberg R, Hansen NI, Shankaran S, Carlo WA, Cotten CM, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Use and utility of C-reactive protein (CRP) in neonatal early-onset sepsis: a secondary analysis of a prospective surveillance study. J Perinatol. 2025 Jan;45(1):139-145. doi: 10.1038/s41372-024-02064-5. Epub 2024 Aug 5.
PubMed 39103472
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-Onset Sepsis an NICHD/CDC Surveillance Study
- ClinicalTrials.gov ID
- NCT02410486
- Acronym / sponsor ID
- EOSII / NICHD-NRN-0055
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Apr 2015 (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 prospective surveillance study will be conducted over a 2 year period to determine current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated pathogens, antimicrobial resistance, signs and symptoms and infant outcomes.
Detailed description
Neonatal pathogens other than group B Streptococcus (GBS) and resistant to beta-lactam antibiotics have emerged as the most common etiologic agents of EOS and EOM among preterm and term neonates and result in high mortality rates, potentially offsetting the decreased burden of early-onset GBS disease prevented by maternal intrapartum chemoprophylaxis.
Primary Outcomes of this study:
- To determine current hospital-based rates of early-onset neonatal infection (total, GA-specific and BW-specific, and pathogen-specific) in term and preterm infants in the era of maternal intrapartum antibiotic prophylaxis to prevent vertical transmission of group B streptococcal disease. Early-onset infection comprises EOS and/or EOM and is defined as isolation of a pathogen from blood or cerebrospinal fluid (CSF) obtained within 72 hours of birth and provision of appropriate antibiotic treatment for 5 or more days (or <5 days if death occurs while receiving antibiotic therapy).
- To determine the antimicrobial susceptibility patterns of organisms associated with EOS and EOM
The case control aspect of this study will address 2 major conundrums regarding EOS: Can we identify risk factors for early-onset Gram-negative infections that might lead to intervention strategies to reduce risk and can we identify infants born to mothers with clinical chorioamnionitis who are at highest risk for early-onset sepsis and thus warrant antibiotic treatment soon after birth?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EOS infant / mother with chorio | – | –Infant with EOS (Gram-positive or Gram-negative) and mother with Chorioamnionitis |
| EOS infant / mother without chorio | – | –Infant with EOS (Gram-positive or Gram-negative) and mother without Chorioamnionitis |
| EOS Gram-neg infant / mother with chorio | – | –Infant with Gram-negative EOS and mother with Chorioamnionitis |
| Gram-neg infant / mother without chorio | – | –Infant with Gram-negative EOS and mother without Chorioamnionitis |
| Gram-pos infant / mother with chorio | – | –Infant with Gram-positive EOS and mother with Chorioamnionitis |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will include all live born infants who are at least 22 weeks GA and have a birth weight >400 grams and are delivered at NRN centers.
Key inclusion criteria (2 listed)
- Case Surveillance: Live born infants with gestational age of at least 22 weeks and birth weight >400 g and <72 hours of age who are delivered at NRN hospitals and have early-onset sepsis and meningitis defined as isolation of a pathogen from blood or CSF obtained within 72 hours of birth and provision of appropriate antibiotic treatment for 5 or more days (or <5 days if death occurs while receiving antibiotic therapy).
- Controls: Live born infants with gestational age of at least 22 weeks and birth weight >400 g who are delivered at NRN hospitals and have not been evaluated for early-onset sepsis (<72 hours of age) or if evaluated, they have sterile blood and/or CSF cultures and were not treated with prolonged antibiotics for clinical "culture negative" sepsis. Controls for infants with Gram-negative infection will be infants without early-onset infection. Controls for infants born to mothers with clinical chorioamnionitis will be infants without early-onset infection born to mothers with clinical chorioamnionitis. Control infants will be born at the same hospital as cases, with the same gestational age grouping as cases (22 0/7 - 28 6/7 weeks; 29 0/7 - 33 6/7 weeks; 34 0/7 - 36 6/7 weeks; and ≥ 37 weeks).
Key exclusion criteria (2 listed)
- Stillbirths and infants who die in the delivery room will be excluded.
- Infants who die within 12 hours of age will be excluded if they have not been evaluated for possible infection-ie, do not have a blood culture obtained to identify EOS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine current hospital-based rates of early-onset neonatal infection
Time frame: First 72 hours
To determine the antimicrobial susceptibility patterns of organisms associated with EOS and EOM
Time frame: First 72 hours
6 secondary outcomes
To identify risk factors associated with EOS/EOM due to Gram-negative pathogens (case control comparison)
Time frame: First 72 hours
To determine the clinical signs/symptoms and laboratory abnormalities associated with EOS/EOM
Time frame: First 72 hours
To identify risk factors for EOS/EOM in infants born to mothers with chorioamnionitis (case control comparison)
Time frame: First 72 hours
To determine if term infants with EOS, identified because of maternal chorioamnionitis, can be asymptomatic at birth
Time frame: First 72 hours
To determine sepsis-associated mortality rates (total, GA-specific and BW-specific, pathogen-specific) for infants with EOS/EOM
Time frame: First 72 hours
To review changes over time in overall rates of EOS and EOM, pathogens associated with infection, risk factors for infection, clinical and laboratory abnormalities, and sepsis-associated mortality
Time frame: 9-11 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Derived from this study: PubMed 39103472Kilpatrick R, Greenberg R, Hansen NI, Shankaran S, Carlo WA, Cotten CM, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Use and utility of C-reactive protein (CRP) in neonatal early-onset sepsis: a secondary analysis of a prospective surveillance study. J Perinatol. 2025 Jan;45(1):139-145. doi: 10.1038/s41372-024-02064-5. Epub 2024 Aug 5.
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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.
Barbara Stoll, MD study director
The University of Texas Health Science Center, Houston
Michele Walsh, MD principal investigator
Case Western Reserve University, Rainbow Babies and Children's Hospita
Seetha Shankaran, MD principal investigator
Wayne State University
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Newborn, Diseases and Early Onset Neonatal Sepsis, run by NICHD Neonatal Research Network at 20 sites in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine current hospital-based rates of early-onset neonatal infection (time frame: First 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02410486, which also lists 1 linked publication.
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 11 Mar 2019.