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Neurodevelopmental Outcomes After Suspected or Proven Sepsis: Secondary Analysis of INIS Trial Database

NCT02281890 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3493

Last updated 2014-11-04

No results posted yet for this study

Summary

Neonatal sepsis is an important determinant of adverse neurodevelopmental outcome. The investigators seek to investigate whether neurodevelopmental outcome following neonatal sepsis differs according to whether or not the diagnosis is confirmed by culture. In a secondary analysis of all 3493 infants included in the International Neonatal Immunotherapy Study (INIS) randomized controlled trial of intravenous immunoglobulin for neonatal sepsis, the investigators will evaluate neurodevelopmental outcomes according to whether or not the sepsis was culture-proven. The primary outcome is death or major disability at two years. In secondary analyses the investigators will determine neurodevelopmental outcomes according to the causative organism identified. Greater understanding of the impact of culture-positivity on long-term outcomes in the setting of clinical neonatal sepsis is essential to better inform parents about the future prospects of their child and to guide patient follow-up.

Conditions

  • Neonatal Sepsis

Interventions

OTHER

Proven sepsis

Exposure is proven sepsis

Sponsors & Collaborators

  • INIS Collaborative Group

    collaborator UNKNOWN

  • Maastricht University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Ben Stenson, MD · University of Edinburgh

  • Peter Brocklehurst, MD · University of Oxford

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2007-09-30
Completion
2007-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02281890 on ClinicalTrials.gov