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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05763316
Collaborator
(none)
300
1
13
23.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CRIB II
  • Other: SNAP-II
  • Other: SNAPPE-II
  • Other: STOPS
  • Other: MSNS
  • Other: nSOFA

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Accuracy of Scoring Systems for Risk Assessment in Neonatal Intensive Care Unit at Sohag University Hospital
Actual Study Start Date :
Mar 12, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 10, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Survival at discharge [One year]

    Proportion of neonates discharged alive from NICU

Secondary Outcome Measures

  1. Length of hospital stay [One year]

    Length of stay in NICU

  2. Need for CPAP [One year]

    Proportion of neonates connected to continuous positive airway pressure

  3. Need for invasive ventilation [One year]

    Proportion of neonates requiring invasive ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 28 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neonatal Intensive Care Units at Sohag University Hospitals Sohag Egypt 82524

Sponsors and Collaborators

  • Sohag University

Investigators

  • Study Chair: Montaser M Mohamed, MD, PhD, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rehab Zain Elabdeen Abdelfattah, Pediatric Resident, Sohag University
ClinicalTrials.gov Identifier:
NCT05763316
Other Study ID Numbers:
  • Soh-Med-23-03-10MS
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2023