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Neonatal DeathNCT05763316

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

An observational study of Neonatal Death, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 28 days
Conditions the study is for
Neonatal Death
What is being tested?
CRIB II, SNAP-II and SNAPPE-II
How many people
300 participants
Where
1 siteEgypt
Study dates
12 Mar 2023to 10 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 28 days
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Rehab Z Abdelftah, MD contact

01062757889

rehabzain@med.sohag.edu.eg

Elsayed Abdelkreem, MD, PhD contact

00201114232126

d.elsayedmohammed@med.sohag.edu.eg

Egypt1 site, 1 recruiting

  • Neonatal Intensive Care Units at Sohag University Hospitals

    Sohag, 82524

    Abdelrahim A Sadek, MD, PhD, abdoneurology@yahoo.com

    Elsayed Abdelkreem, MD, PhD

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Conditions
Neonatal Death
Being tested
CRIB II, SNAP-II, SNAPPE-II, STOPS, MSNS
Medical subject headings
Perinatal Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRIB IIOther

    Calculate Clinical Risk Index for Babies II score

  • SNAP-IIOther

    Calculate Score for Neonatal Acute Physiology II

  • SNAPPE-IIOther

    Calculate Score for Neonatal Acute Physiology Perinatal Extension II

  • STOPSOther

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

  • MSNSOther

    Calculate Modified Sick neonatal Score

  • nSOFAOther

    Calculate neonatal sequential organ failure assessment

Study groups in NCT05763316
Study groupRoleWhat they receive
Study participantsNeonates admitted to NICU and fulfilling eligibility criteria
Receives: Other: CRIB II; Other: SNAP-II; Other: SNAPPE-II; Other: STOPS; Other: MSNS; Other: nSOFA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival at discharge

    Proportion of neonates discharged alive from NICU

    Measured: One year

Secondary outcomes (3)

  1. Length of hospital stay

    Length of stay in NICU

    Measured: One year

  2. Need for CPAP

    Proportion of neonates connected to continuous positive airway pressure

    Measured: One year

  3. Need for invasive ventilation

    Proportion of neonates requiring invasive ventilation

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start12 Mar 2023
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion10 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763316
Sponsor's protocol ID
Soh-Med-23-03-10MS
Status last verified
Mar 2023
First submitted
28 Feb 2023
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unidentified individual participant data will be available from the principal investigator upon a reasonable request

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.

    PubMed 28372507

  • 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.

    PubMed 35524143

  • 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.

    PubMed 12781540

  • 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.

    PubMed 11148519

  • 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.

    PubMed 36136230

  • 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.

    PubMed 31210987

  • 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.

    PubMed 31394566

  • 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.

    PubMed 26266178

Questions about this trial

What is this clinical trial studying?

An observational study of Neonatal Death, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rehab Z Abdelftah, MD (01062757889, rehabzain@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival at discharge (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05763316, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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