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

NCT ID: NCT05763316

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-12

Study Completion Date

2024-04-10

Brief Summary

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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

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Conditions

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Neonatal Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study participants

Neonates admitted to NICU and fulfilling eligibility criteria

CRIB II

Intervention Type OTHER

Calculate Clinical Risk Index for Babies II score

SNAP-II

Intervention Type OTHER

Calculate Score for Neonatal Acute Physiology II

SNAPPE-II

Intervention Type OTHER

Calculate Score for Neonatal Acute Physiology Perinatal Extension II

STOPS

Intervention Type OTHER

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

MSNS

Intervention Type OTHER

Calculate Modified Sick neonatal Score

nSOFA

Intervention Type OTHER

Calculate neonatal sequential organ failure assessment

Interventions

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CRIB II

Calculate Clinical Risk Index for Babies II score

Intervention Type OTHER

SNAP-II

Calculate Score for Neonatal Acute Physiology II

Intervention Type OTHER

SNAPPE-II

Calculate Score for Neonatal Acute Physiology Perinatal Extension II

Intervention Type OTHER

STOPS

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

Intervention Type OTHER

MSNS

Calculate Modified Sick neonatal Score

Intervention Type OTHER

nSOFA

Calculate neonatal sequential organ failure assessment

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Rehab Zain Elabdeen Abdelfattah

Pediatric Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Montaser M Mohamed, MD, PhD

Role: STUDY_CHAIR

Sohag University

Locations

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Neonatal Intensive Care Units at Sohag University Hospitals

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rehab Z Abdelftah, MD

Role: CONTACT

01062757889

Elsayed Abdelkreem, MD, PhD

Role: CONTACT

00201114232126

Facility Contacts

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Abdelrahim A Sadek, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28372507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35524143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12781540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11148519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36136230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31210987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31394566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26266178 (View on PubMed)

Other Identifiers

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Soh-Med-23-03-10MS

Identifier Type: -

Identifier Source: org_study_id

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