Clinical trial NCT05763316: Accuracy of Scoring Systems for Risk Assessment in Neonatal Intensive Care Unit
Official title: Accuracy of Scoring Systems for Risk Assessment in Neonatal Intensive Care Unit at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Death
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 300
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates admitted to NICUs at Sohag University Hospitals during the study duration

Brief summary: Early detection of neonates with higher risk of death is quite important for paying more attention to these cases, timely referral to tertiary neonatal intensive care unit (NICU), and provision of meticulous critical care, which ultimately may improve outcomes. Several scoring systems have recently been developed for assessment of the intensity of illness and prognosticate the risk of not only neonatal mortality but also short- and long-term morbidities. The accuracy of these scoring systems has been investigated in several NICUs from different countries, such as USA, UK, Canada, Brazil, India, and Iran. Previous Egyptian studies have investigated the accuracy of Clinical Risk Index for Babies II (CRIB II), Score for Neonatal Acute Physiology II (SNAP-II) and its Perinatal Extension II (SNAPPE-II). However, the accuracy of Sensorium, temperature, oxygenation, perfusion, skin color, and blood sugar (STOPS), Modified Sick neonatal Score (MSNS), and neonatal sequential organ failure assessment (nSOFA) has not been investigated in Egyptian NICUs. Therefore, more studies are required to investigate the utility and accuracy of neonatal risk assessment scores in Egyptian NICUs.


Eligibility criteria: Inclusion Criteria:

* Admission within 24 hours after birth.
* Length of hospital stay at the first admission to NICU ≥12 hours

Exclusion Criteria:

* Major congenital anomalies.
* Discharge against medical advice
* Transportation to other places.
* Missing data on items of scoring systems

Primary outcomes:
measure: Survival at discharge
timeFrame: One year
Secondary outcomes:
measure: Length of hospital stay
timeFrame: One year
measure: Need for CPAP
timeFrame: One year
measure: Need for invasive ventilation
timeFrame: One year
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Neonatal Intensive Care Units at Sohag University Hospitals
Study officials:
affiliation: Sohag University
name: Montaser M Mohamed, MD, PhD
role: STUDY_CHAIR
References:
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