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

Severity Index of Neonatal Septicemia of Cases Admitted at Neonatal Intensive Care Units at CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and at ELGALAA Children's MILITARY HOSPITAL Using Score for Neonatal Acute Physiology (SNAP) II

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.

Study Overview

• Status: Completed
• Conditions: Neonatal SEPSIS
• Intervention / Treatment: Diagnostic test: score for neonatal sepsis

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Faculty of medicine cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm neonates; Neonates born between 32 and 37 weeks gestation	Diagnostic test: score for neonatal sepsis; score for neonatal sepsis to predict morbidity
Fullterm neonates; Neonates born at or after 37 weeks gestation	Diagnostic test: score for neonatal sepsis; score for neonatal sepsis to predict morbidity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Ahmed Mahmoud Ali Ali Youssef
• Investigators: Principal Investigator: Nermin R Mohamed, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): September 14, 2018

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (ACTUAL): November 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Neonatal Sepsis
• Other Study ID Numbers: SNAP II Score

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No