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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03746743
Acronym
SNAP
Enrollment
100
Registered
2018-11-20
Start date
2017-09-01
Completion date
2018-09-14
Last updated
2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal SEPSIS

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.

Interventions

DIAGNOSTIC_TESTscore for neonatal sepsis

score for neonatal sepsis to predict morbidity

Sponsors

Ahmed Mahmoud Ali Ali Youssef
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome.through study completion, an average of 1 year

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026