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

Neonatal Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763316
• Other study ID #: Soh-Med-23-03-10MS
• Status: Recruiting
• Start date: March 12, 2023
• Est. completion date: April 10, 2024

Study information

• Verified date: March 2023
• Source: Sohag University
• Contact: Rehab Z Abdelftah, MD
• Phone: 01062757889
• Email: rehabzain[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 10, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Death
• Perinatal Death

Intervention

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

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Units at Sohag University Hospitals	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at discharge	Proportion of neonates discharged alive from NICU	One year
Secondary	Length of hospital stay	Length of stay in NICU	One year
Secondary	Need for CPAP	Proportion of neonates connected to continuous positive airway pressure	One year
Secondary	Need for invasive ventilation	Proportion of neonates requiring invasive ventilation	One year