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Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent

H

Hillel Yaffe Medical Center

Status

Unknown

Conditions

Neonatal Sepsis

Study type

Observational

Funder types

Other

Identifiers

NCT02061150
HYMC-104-13

Details and patient eligibility

About

Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.

Enrollment

800 estimated patients

Sex

All

Ages

Under 48 hours old

Volunteers

No Healthy Volunteers

Inclusion criteria

Term newborns with blood cultures taken from them the first 48 hrs

Exclusion criteria

  • Preterm newborns
  • Septic/ill appearing newborns
  • Newborns requiring admission to NICU

Trial design

800 participants in 1 patient group

Asymptomatic newborns that had sepsis workup
Description:
Evaluation of medical records of asymptomatic newborns that had sepsis workup in the first 48 hours of life.

Trial contacts and locations

1

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Central trial contact

Amit Hochberg, MD

Data sourced from clinicaltrials.gov

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