Accuracy of Scoring Systems for Risk Assessment in Neonatal Intensive Care Unit

Recruiting

• Conditions: Neonatal Death
• Interventions: Other: CRIB II; Other: SNAP-II; Other: SNAPPE-II; Other: STOPS; Other: MSNS; Other: nSOFA

• Registration Number: NCT05763316
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Status Verified: 2023-03
• Study First Posted: 2023-03-10
• Study Start: 2023-03-12
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-15
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study participants	SNAP-II	Neonates admitted to NICU and fulfilling eligibility criteria
Study participants	SNAPPE-II	Neonates admitted to NICU and fulfilling eligibility criteria
Study participants	nSOFA	Neonates admitted to NICU and fulfilling eligibility criteria
Study participants	STOPS	Neonates admitted to NICU and fulfilling eligibility criteria
Study participants	MSNS	Neonates admitted to NICU and fulfilling eligibility criteria
Study participants	CRIB II	Neonates admitted to NICU and fulfilling eligibility criteria

Primary Outcome Measures

Name	Time	Method
Survival at discharge	One year	Proportion of neonates discharged alive from NICU

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	One year	Length of stay in NICU
Need for CPAP	One year	Proportion of neonates connected to continuous positive airway pressure
Need for invasive ventilation	One year	Proportion of neonates requiring invasive ventilation

Trial Locations

Locations (1)

Neonatal Intensive Care Units at Sohag University Hospitals; 🇪🇬 Sohag, Egypt