Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Exclusion criteria:
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:
Full history with emphasis of relevant data as follows:
Date of birth, gestational age (AGA or SGA), gender, day of sepsis onset.
Clinical assessment:
Full systems examination.
Diagnosis of sepsis:
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).
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:
Follow up:
Follow up all neonates included in the study for 14 days: for morbidity and mortality.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm neonates | Neonates born between 32 and 37 weeks gestation |
| |
| Fullterm neonates | Neonates born at or after 37 weeks gestation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| score for neonatal sepsis | Diagnostic Test | score for neonatal sepsis to predict morbidity |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Early anticipation of clinical manifestations of sepsis which will correlate most with poor outcome. | through study completion, an average of 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Neonates with septicemia admitted to NICUs in CHILDREN'S HOSPITAL, CAIRO UNIVERSITY and in ELGALAA Children's MILITARY HOSPITAL.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nermin R Mohamed, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Of medicine Cairo University | Giza | 12613 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |