Faculty Of medicine Cairo University
Giza, 12613, Egypt
NCT Number: NCT03746743
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.
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All sexes
Observational
Giza, 12613, Egypt
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:
Date of birth, gestational age (AGA or SGA), gender, day of sepsis onset.
Full systems examination.
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).
For all neonates included in the study and its data collection within 24 hours from onset of sepsis, in the form of:
Follow up all neonates included in the study for 14 days: for morbidity and mortality.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
score for neonatal sepsis to predict morbidity
Time frame: through study completion, an average of 1 year
Time frame: through study completion, an average of 1 year
Ahmed Mahmoud Ali Ali Youssef
Other
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
Acronym: SNAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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