Early-Onset Sepsis Surveillance Study

NCT00874367 | Completed DMC

• 39 other identifiers: NICHD-NRN-0035U10HD021364U10HD021373U10HD021385U10HD027851U10HD027853U10HD027856U10HD027871U10HD027880U10HD027904U10HD034216U10HD036790U10HD040492U10HD040498U10HD040521U10HD040689U10HD053089U10HD053109U10HD053119U10HD053124UL1RR024139UL1RR025744UL1RR025764UL1RR025777M01RR000030M01RR000032M01RR000039M01RR000044M01RR000054M01RR000059M01RR000064M01RR000070M01RR000080M01RR000633M01RR000750M01RR000997M01RR008084M01RR006022M01RR007122
• Study Type: observational
• Target: 615
• Locations: 1 country
• Sites: 19

Brief Summary

In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis. The study will: establish current hospital-based rates of EOS among term and preterm infants in the era of intrapartum antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare asymptomatic and symptomatic infants by gestational age and pathogen; and monitor sepsis-associated mortality rates by pathogen group.

Conditions

Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Sepsis; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections

Keywords

NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Prematurity; Early Onset Sepsis

Outcome Measures

Primary Outcomes (1)

• Early onset sepsis infections

  Until hospital discharge

Secondary Outcomes (5)

• Group B streptococcal (GBS) infections

  Until hospital discharge

• Symptomatic early onset sepsis infections

  Until hospital discharge

• Death with early gram-negative or early gram-positive infections

  Until hospital discharge

• Prolonged exposure to maternal intrapartum antibiotics (>24 hours)

  Prenatal

• Placental examinations to confirm clinical diagnosis of chorioamnionitis

  Prenatal

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All live born infants \>400g birth weight delivered at NICHD Neonatal Research Network participating hospitals

You may qualify if:

• Infants \>400g birth weight

You may not qualify if:

• Stillbirth or death in the delivery room

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• Centers for Disease Control and Prevention: collaborator
• National Center for Research Resources (NCRR): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (19)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Wake Forest University

Charlotte, North Carolina, 27157, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.

  PMID: 21518717 BACKGROUND

Related Links

• NICHD Neonatal Research Network

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of the isolated pathogens

MeSH Terms

Conditions

Premature Birth; Sepsis; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Abbot R. Laptook, MD

  Brown University, Women & Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Michele C. Walsh, MD MS

  Case Western Reserve University, Rainbow Babies and Children's Hospital

  PRINCIPAL INVESTIGATOR

• Ronald N. Goldberg, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Brenda B. Poindexter, MD MS

  Indiana University

  PRINCIPAL INVESTIGATOR

• Abhik Das, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Krisa P. Van Meurs, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ivan D. Frantz III, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Kurt Schibler, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Waldemar A. Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Edward F. Bell, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Kristi L. Watterberg, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Pablo J. Sanchez, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Kathleen A. Kennedy, MD MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Roger G. Faix, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Richard A. Ehrenkranz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Dale L. Phelps, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• T. Michael O'Shea, MD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: February 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2011
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

US (19)