NCT03746743

Brief Summary

To determine the effect of Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia in the Neonatal Intensive Care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

12 months

First QC Date

November 13, 2018

Last Update Submit

November 16, 2018

Conditions

Neonatal SEPSIS

Outcome Measures

Primary Outcomes (1)

  • Using Score for Neonatal Acute Physiology II as a Predictor of Mortality and Organ Dysfunction in Neonates with Septicemia.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome.

    through study completion, an average of 1 year

Study Arms (2)

Preterm neonates

Neonates born between 32 and 37 weeks gestation

Diagnostic Test: score for neonatal sepsis

Fullterm neonates

Neonates born at or after 37 weeks gestation

Diagnostic Test: score for neonatal sepsis

Interventions

score for neonatal sepsisDIAGNOSTIC_TEST

score for neonatal sepsis to predict morbidity

Fullterm neonatesPreterm neonates

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.

You may qualify if:

  • Type of patient: Neonates with septicemia.
  • Age of patient: From 0-28 Days.
  • Sex: males and females.

You may not qualify if:

  • Neonates with proved inborn error of metabolism.
  • Neonates with multiple congenital anomalies.
  • Neonates with severe birth asphyxia (APGAR score \<4 at 5 minutes).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of medicine Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nermin R Mohamed, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 20, 2018

Study Start

September 1, 2017

Primary Completion

August 31, 2018

Study Completion

September 14, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)