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NCT06113653 Clinical Trial

Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis

Neonatal Sepsis Clinical Trial

Official title:
Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis Admitted in NICU of Assiut University Children's Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06113653
Other study ID # Outcomes of neonatal sepsis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 28, 2023
Est. completion date March 31, 2025

Study information
Verified date October 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective cross-sectional study of outcomes and predictors of mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut University Children's Hospital

Description:

Neonatal sepsis is a clinical syndrome of bacteremia with systemic signs and symptoms of infection in the first 28 days of life. It can also result from viral and fungal invasions of the bloodstream It is one of the events that can occur during neonatal intensive care unit (NICU) admission. It contributes significantly to the morbidity of very preterm (VP: <32 weeks gestational age) and/or very low birthweight (VLBW: <1500 g) infants Sepsis is a major cause of neonatal mortality and neurodevelopmental impairment among neonates which results in death and major disability for 39% of those affected even with timely antibiotic treatment . Globally, it is estimated that more than 1.4 million neonatal deaths annually are the consequence of invasive infections . Infection-specific mortality varies by geographic region and neonatal risk factors like gestational age and body weight . It contributes to nearly 30-50% of neonatal deaths in developing countries . The risk of death is highest in the first 24 h of life when more than half of deaths occur and about three-quarters of all neonatal deaths occur within the first week of life.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date March 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 1 Minute to 28 Days
Eligibility Inclusion Criteria: - All preterm infants (<37 weeks) diagnosed with neonatal sepsis - Preterm infants aged 0-28 days Exclusion Criteria: - Full term infants (> 37 weeks gestation) -Neonates with congenital anomalies -Neonates diagnosed with metabolic diseases - Neonates with birth asphyxia

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Prospective study
Prospective study of outcomes and predictors of mortality among preterm infants with neonatal sepsis

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary mortality among preterm infants with neonatal sepsis mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut university children's hospital Baseline
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