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Preliminary results on validity and reliability from two prospective cohort studies on a new Neonatal Coma Score
  1. Anthony Richard Hart1,2,
  2. Martha Kieran3,
  3. Elizabeth Matthews3,
  4. Laura Mandefield4,
  5. Tamanna Williams5,
  6. Kathryn Johnson6,
  7. Sharon English6,
  8. Denise Evans7,
  9. Lisa Cutsey8,
  10. John Goodden9
  1. 1 Department of Paediatric Neurology, King's College Hospital NHS Foundation Trust, London, UK
  2. 2 King's College London, Division of Health and Social Care Research, London, UK
  3. 3 Medical School, The University of Sheffield, Sheffield, UK
  4. 4 York Trials Unit, Department of Health Sciences, University of York, York, UK
  5. 5 Deparment of Neonatology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
  6. 6 Department of Neonatology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  7. 7 Neonatal Education, Yorkshire and Humber Neonatal Operational Delivery Network, Sheffield, UK
  8. 8 Department of Paediatric Neurology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  9. 9 Department of Paediatric Neurosurgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK
  1. Correspondence to Dr Anthony Richard Hart, Paediatric Neurology, King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK; anthony.hart{at}kcl.ac.uk

Abstract

Objective To collect data on content/face validity and interobserver agreement for a Neonatal Coma Score (NCS) in well full-term neonates and on construct validity in unwell and preterm babies, specifically how the NCS changed with gestational age and illness.

Design Prospective cohort studies.

Setting Two UK tertiary neonatal units (Sheffield and Leeds).

Patients 151 well full-term (≥37 weeks gestational age) newborn babies recruited between January and February 2020 in Sheffield and April and May 2021 in Leeds; 101 sick preterm and full-term babies admitted to Sheffield neonatal unit between January 2021 and May 2022.

Intervention A new NCS.

Main outcome measures Determination of normal values in well babies born ≥37 weeks gestational age; data on how the NCS changes with gestational age and illness.

Results Face validity was demonstrated during development of the NCS. The median NCS of well, full-term newborn babies was 15 and the intraclass correlation coefficient was 0.78 (95% CI 0.70 to 0.84). In the ‘well’ preterm population, 95% <28 weeks had a score ≥11; 28–31 weeks ≥11; 32–36 weeks ≥13 and 37–44 weeks 14–15. The NCS dropped during periods of deterioration, demonstrating evidence of construct validity. Criterion validity was not assessed.

Conclusions The NCS has good intraobserver agreement in well full-term babies, with a normal NCS 14–15. The NCS in preterm neonates depended on gestational age, and deterioration from baseline was associated with illness. Further work is needed to determine normal scores each gestational age, reliability at lower levels, how early the NCS identifies deterioration and comparison with other assessment tools to demonstrate criterion validity.

  • intensive care units, neonatal
  • neonatology
  • neurology
  • nursing care

Data availability statement

Data are available on reasonable request.

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Data availability statement

Data are available on reasonable request.

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Footnotes

  • Twitter @dr_kej

  • Contributors ARH helped devise the NCS, gained ethical approval, supervised the project, reviewed medical notes, analysed data and wrote the paper. He was responsbile for the overall content as guarantor, accepts full responsibility for the finished work and the conduct of the study, had access to the data, and controlled the decision to publish. MK recruited unwell preterm and term participants to the study, reviewed the medical notes, analysed the data and contributed to the final version of the paper. EM recruited well full-term babies, reviewed the medical notes, analysed data and contributed to the final version of the paper. LM is a senior statistician, who reviewed and commented on the statistical methodology and results and contributed to the final draft of the paper. TW, KJ and SE helped run the study, provided advice on the NCS in neonatal care, provided training for members of staff and contributed to the final version of the paper. DE helped devise the NCS, provided information from a neonatal neonatal nurse perspective, helped design the study and contributed to the final version of the paper. LC helped devise the NCS, provided information from a paediatric neonatal nurse perspective, helped design the study and contributed to the final version of the paper. JG helped conceive the concept of the NCS, design the NCS and research study and contributed to the final version of the paper.

  • Funding Part funding was provided by the Yorkshire and Humber Neuroscience Operational Delivery Network, the Medical School, University of Sheffield and internal resources of the Department of Paediatric Neurology, Sheffield Children’s NHS Foundation Trust.

  • Disclaimer The funders had no role in study design, interpretation of results or decision to publish.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.