Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06113653
• Collaborator: (none)
• Enrollment: 50
• Anticipated Duration (Months): 17.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neonatal Sepsis	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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis Admitted in NICU of Assiut University Children's Hospital
• Anticipated Study Start Date: Oct 28, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Mar 31, 2025

Outcome Measures

Primary Outcome Measures

1. mortality among preterm infants with neonatal sepsis [Baseline]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Minute to 28 Days
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yasmine Thabet Ragab, 71515assiut, Assiut University
• ClinicalTrials.gov Identifier: NCT06113653
• Other Study ID Numbers: Outcomes of neonatal sepsis
• First Posted: Nov 2, 2023
• Last Update Posted: Nov 2, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sepsis; Toxemia; Neonatal Sepsis

Study Results

No Results Posted as of Nov 2, 2023