Severity Index of Neonatal Septicemia Using Score for Neonatal Acute Physiology (SNAP) II
Condition: Neonatal SEPSIS
MeSH terms: Neonatal Sepsis; Sepsis
Study type: Observational [Patient Registry]

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.
    

Intervention name(s): score for neonatal sepsis
Intervention type(s): Diagnostic Test
Intervention description(s): score for neonatal sepsis to predict morbidity
Observational model: Cohort
Time perspective: Prospective
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.