Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis

NCT ID: NCT06113653

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-28

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Neonatal Sepsis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Prospective study

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Yasmine Thabet Ragab

71515assiut

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Outcomes of neonatal sepsis

Identifier Type: -

Identifier Source: org_study_id

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