Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis

Not yet recruiting

• Conditions: Neonatal Sepsis

• Registration Number: NCT06113653
• Lead Sponsor: Assiut University

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-28
• Study First Submitted: 2023-10-28
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-02
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality among preterm infants with neonatal sepsis	Baseline	mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut university children's hospital