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

NCT05763316 | Unknown

• 1 other identifier: Soh-Med-23-03-10MS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Death

Outcome Measures

Primary Outcomes (1)

• Survival at discharge

  Proportion of neonates discharged alive from NICU

  One year

Secondary Outcomes (3)

• Length of hospital stay

  One year

• Need for CPAP

  One year

• Need for invasive ventilation

  One year

Study Arms (1)

Study participants

Neonates admitted to NICU and fulfilling eligibility criteria

Other: CRIB II; Other: SNAP-II; Other: SNAPPE-II; Other: STOPS; Other: MSNS; Other: nSOFA

Interventions

CRIB II OTHER

Calculate Clinical Risk Index for Babies II score

Study participants

SNAP-II OTHER

Calculate Score for Neonatal Acute Physiology II

Study participants

SNAPPE-II OTHER

Calculate Score for Neonatal Acute Physiology Perinatal Extension II

Study participants

STOPS OTHER

Calculate Sensorium, temperature, oxygenation, perfusion, skin color, and blood sugar score

Study participants

MSNS OTHER

Calculate Modified Sick neonatal Score

Study participants

nSOFA OTHER

Calculate neonatal sequential organ failure assessment

Study participants

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Neonatal Intensive Care Units at Sohag University Hospitals

Sohag, 82524, Egypt

RECRUITING

Related Publications (8)

• 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.

  PMID: 28372507 BACKGROUND

• 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.

  PMID: 35524143 BACKGROUND

• 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.

  PMID: 12781540 BACKGROUND

• 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.

  PMID: 11148519 BACKGROUND

• 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. 2023 Aug;90(8):781-786. doi: 10.1007/s12098-022-04330-w. Epub 2022 Sep 22.

  PMID: 36136230 BACKGROUND

• 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.

  PMID: 31210987 BACKGROUND

• 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.

  PMID: 31394566 BACKGROUND

• 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.

  PMID: 26266178 BACKGROUND

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Montaser M Mohamed, MD, PhD

  Sohag University

  STUDY CHAIR

Central Study Contacts

Rehab Z Abdelftah, MD

CONTACT

01062757889; rehabzain@med.sohag.edu.eg

Elsayed Abdelkreem, MD, PhD

CONTACT

00201114232126; d.elsayedmohammed@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Resident

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: March 12, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 10, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication and for three years
• Access Criteria: Available from the principal investigator upon a reasonable request

Locations

EG (1)