NCT06113653

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 28, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

October 28, 2023

Last Update Submit

November 1, 2023

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

  • mortality among preterm infants with neonatal sepsis

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

    Baseline

Interventions

Prospective studyOTHER

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

Eligibility Criteria

Age1 Minute - 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All preterm infants diagnosed with neonatal sepsis

You may qualify if:

  • All preterm infants (\<37 weeks) diagnosed with neonatal sepsis
  • Preterm infants aged 0-28 days

You may not qualify if:

  • Full term infants (\> 37 weeks gestation) -Neonates with congenital anomalies -Neonates diagnosed with metabolic diseases
  • Neonates with birth asphyxia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Prospective Studies

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
71515assiut

Study Record Dates

First Submitted

October 28, 2023

First Posted

November 2, 2023

Study Start

October 28, 2023

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

November 2, 2023

Record last verified: 2023-10