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

Accuracy of Scoring Systems for Risk Assessment in Neonatal Intensive Care Unit at Sohag University Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Death
• Intervention / Treatment: Other: CRIB II; Other: SNAP-II; Other: SNAPPE-II; Other: STOPS; Other: MSNS; Other: nSOFA

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Elsayed Abdelkreem, MD, PhD; Phone Number: 00201114232126; Email: d.elsayedmohammed@med.sohag.edu.eg
• Study Contact Backup: Name: Rehab Z Abdelftah, MD; Phone Number: 01062757889; Email: rehabzain@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Recruiting
    • Neonatal Intensive Care Units at Sohag University Hospitals
    • Contact: Abdelrahim A Sadek, MD, PhD; Email: abdoneurology@yahoo.com
    • Principal Investigator: Elsayed Abdelkreem, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates admitted to NICUs at Sohag University Hospitals during the study duration

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study participants; Neonates admitted to NICU and fulfilling eligibility criteria

Other: CRIB II; Calculate Clinical Risk Index for Babies II score; Other: SNAP-II; Calculate Score for Neonatal Acute Physiology II; Other: SNAPPE-II; Calculate Score for Neonatal Acute Physiology Perinatal Extension II; Other: STOPS; Calculate Sensorium, temperature, oxygenation, perfusion, skin color, and blood sugar score; Other: MSNS; Calculate Modified Sick neonatal Score; Other: nSOFA; Calculate neonatal sequential organ failure assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival at discharge	Proportion of neonates discharged alive from NICU	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of stay in NICU	One year
Need for CPAP	Proportion of neonates connected to continuous positive airway pressure	One year
Need for invasive ventilation	Proportion of neonates requiring invasive ventilation	One year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Garg B, Sharma D, Farahbakhsh N. Assessment of sickness severity of illness in neonates: review of various neonatal illness scoring systems. J Matern Fetal Neonatal Med. 2018 May;31(10):1373-1380. doi: 10.1080/14767058.2017.1315665. Epub 2017 Apr 20.
• Vardhelli V, Murki S, Tandur B, Saha B, Oleti TP, Deshabhotla S, Mohammed YA, Seth S, Siramshetty S, Kallem VR. Comparison of CRIB-II with SNAPPE-II for predicting survival and morbidities before hospital discharge in neonates with gestation </= 32 weeks: a prospective multicentric observational study. Eur J Pediatr. 2022 Jul;181(7):2831-2838. doi: 10.1007/s00431-022-04463-2. Epub 2022 May 6.
• Parry G, Tucker J, Tarnow-Mordi W; UK Neonatal Staffing Study Collaborative Group. CRIB II: an update of the clinical risk index for babies score. Lancet. 2003 May 24;361(9371):1789-91. doi: 10.1016/S0140-6736(03)13397-1.
• Richardson DK, Corcoran JD, Escobar GJ, Lee SK. SNAP-II and SNAPPE-II: Simplified newborn illness severity and mortality risk scores. J Pediatr. 2001 Jan;138(1):92-100. doi: 10.1067/mpd.2001.109608.
• Vardhelli V, Seth S, Mohammed YA, Murki S, Tandur B, Saha B, Oleti TP, Deshabhotla S, Siramshetty S, Kallem VR. Comparison of STOPS and SNAPPE-II in Predicting Neonatal Survival at Hospital Discharge: A Prospective, Multicentric, Observational Study. Indian J Pediatr. 2022 Sep 22. doi: 10.1007/s12098-022-04330-w. Online ahead of print.
• Mansoor KP, Ravikiran SR, Kulkarni V, Baliga K, Rao S, Bhat KG, Baliga BS, Kamath N. Modified Sick Neonatal Score (MSNS): A Novel Neonatal Disease Severity Scoring System for Resource-Limited Settings. Crit Care Res Pract. 2019 May 9;2019:9059073. doi: 10.1155/2019/9059073. eCollection 2019.
• Wynn JL, Polin RA. A neonatal sequential organ failure assessment score predicts mortality to late-onset sepsis in preterm very low birth weight infants. Pediatr Res. 2020 Jul;88(1):85-90. doi: 10.1038/s41390-019-0517-2. Epub 2019 Aug 8.
• Ezz-Eldin ZM, Hamid TA, Youssef MR, Nabil Hel-D. Clinical Risk Index for Babies (CRIB II) Scoring System in Prediction of Mortality in Premature Babies. J Clin Diagn Res. 2015 Jun;9(6):SC08-11. doi: 10.7860/JCDR/2015/12248.6012. Epub 2015 Jun 1.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 10, 2024

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Perinatal Death
• Other Study ID Numbers: Soh-Med-23-03-10MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Unidentified individual participant data will be available from the principal investigator upon a reasonable request
• IPD Sharing Time Frame: After publication and for three years
• IPD Sharing Access Criteria: Available from the principal investigator upon a reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No