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

NCT ID: NCT03746743

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-09-14

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.

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.

Conditions

Neonatal SEPSIS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preterm neonates

Neonates born between 32 and 37 weeks gestation

score for neonatal sepsis

Intervention Type: DIAGNOSTIC_TEST

score for neonatal sepsis to predict morbidity

Fullterm neonates

Neonates born at or after 37 weeks gestation

score for neonatal sepsis

Intervention Type: DIAGNOSTIC_TEST

score for neonatal sepsis to predict morbidity

Interventions

score for neonatal sepsis

score for neonatal sepsis to predict morbidity

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Mahmoud Ali Ali Youssef

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mahmoud Ali Ali Youssef

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nermin R Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty Of medicine Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

SNAP II Score

Identifier Type: -

Identifier Source: org_study_id