Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Neonatal Sepsis
• Intervention / Treatment: Other: Prospective study

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 Type: Observational
• Enrollment (Estimated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All preterm infants diagnosed with neonatal sepsis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality among preterm infants with neonatal sepsis	mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut university children's hospital	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): October 28, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: October 28, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis
• Other Study ID Numbers: Outcomes of neonatal sepsis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No