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CompletedNCT03746743SNAPUpdated Nov 20, 2018

Severity Index of Neonatal Septicemia Using Score for Neonatal Acute Physiology (SNAP) II

An observational study in Neonatal SEPSIS, sponsored by Ahmed Mahmoud Ali Ali Youssef. Completed at 1 site in Egypt. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2018-11-20.

Sponsored by Ahmed Mahmoud Ali Ali Youssef · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
1 Day to 28 Days
Sex
All
01

Study 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.

Read the detailed description

This study will be conducted at the Neonatal intensive care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL.

Population of study \& disease condition:

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

Inclusion criteria:

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

Exclusion criteria:

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

Methodology in details:

We will have 2 groups, each of them 50 neonates with septicemia. One group of premature neonates (32-36 weeks), the other group of full term neonates (>37 weeks).

All included Patients will be subjected to the following:

  1. Full history with emphasis of relevant data as follows:

    Date of birth, gestational age (AGA or SGA), gender, day of sepsis onset.

  2. Clinical assessment:

    Full systems examination.

  3. Diagnosis of sepsis:

    • By abnormal Total leucocytic count or I/T ratio or CRP with clinical Suggestion (poor feeding, hepatomegaly, apnea, tachypnea, lethargy, ...).
    • Confirm diagnosis by blood culture.

    Sepsis will be considered severe if the neonate has sepsis plus one of the following: 1) cardiovascular organ dysfunction (hypotension or need for vasoactive drug) 2) 2 of the following (metabolic acidosis, increase lactic acid, oliguria, Prolonged capillary refill time) 3) Organ dysfunction (respiratory, renal, neurologic, hematologic).

  4. SNAP II score:

    For all neonates included in the study and its data collection within 24 hours from onset of sepsis, in the form of:

    • Lowest mean blood pressure.
    • Worst ratio of pao2/fio2
    • Lowest temperature.
    • Lowest serum PH.
    • Occurrence of multiple seizures.
    • Urine output\<1 ml/kg/hour.
  5. Follow up:

    Follow up all neonates included in the study for 14 days: for morbidity and mortality.

  6. Diagnosis of organ dysfunction:

Respiratory: by CXR and clinical examination. CVS: by blood pressure, capillary refill time, shock and need for inotropes. Renal: by urine output, kidney function tests. Hematology: by picture of DIC or pancytopenia. Neurology: by seizures, dilated fixed pupil.

Possible Risk:

None.

Primary outcomes:

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

Secondary outcomes:

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

Sample size:

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

02

Conditions studied

  • Neonatal SEPSIS
03

In context

Neonatal Sepsis

183 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.

This study's enrollment of 100 is below the median of 200 across 84 observational studies indexed under Neonatal Sepsis.

Browse Neonatal Sepsis studies →

Lead sponsor

This is the only study on the registry with Ahmed Mahmoud Ali Ali Youssef as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Neonates with proved inborn error of metabolism.
  2. Neonates with multiple congenital anomalies.
  3. Neonates with severe birth asphyxia (APGAR score \<4 at 5 minutes).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Target follow-up
14 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testscore for neonatal sepsis

    score for neonatal sepsis to predict morbidity

06

What researchers measure

Primary outcomes

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

    Time frame: 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.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Faculty Of medicine Cairo University
    Giza, 12613, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03746743
Lead sponsor
Ahmed Mahmoud Ali Ali Youssef
Responsible party
Ahmed Mahmoud Ali Ali Youssef (Doctor, Cairo University) — Sponsor-investigator
First posted
Nov 20, 2018
Start date
Sep 1, 2017
Primary completion
Aug 31, 2018
Completion
Sep 14, 2018
Last update
Nov 20, 2018

Study contacts

Nermin R Mohamed, MD
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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