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Original article
Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation
  1. A David Edwards1,
  2. Maggie E Redshaw2,
  3. Nigel Kennea3,
  4. Oliver Rivero-Arias2,
  5. Nuria Gonzales-Cinca1,
  6. Phumza Nongena4,
  7. Moegamad Ederies4,
  8. Shona Falconer1,
  9. Andrew Chew1,
  10. Omar Omar2,
  11. Pollyanna Hardy2,
  12. Merryl Elizabeth Harvey5,
  13. Oya Eddama2,
  14. Naomi Hayward4,
  15. Julia Wurie1,
  16. Denis Azzopardi1,
  17. Mary A Rutherford1,
  18. Serena Counsell1
  19. on behalf of the ePrime Investigators
  1. 1 Centre for the Developing Brain, School of Bioengineering and Imaging Sciences, King’s College London and Evelina London Children’s Hospital, London, UK
  2. 2 National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK
  3. 3 Neonatal Unit, St George’s Hospital, London, UK
  4. 4 Division of Clinical Sciences, Imperial College London, London, UK
  5. 5 Faculty of Health, School of Midwifery, Nursing and Social Work, Birmingham City University, Birmingham, UK
  1. Correspondence to Professor A David Edwards, Centre for the Developing Brain, School of Bioengineering and Imaging Sciences, King’s College London and Evelina Children’s Hospital, London SE1 7EH, UK; ad.edwards{at}kcl.ac.uk

Abstract

Background We tested the hypothesis that routine MRI would improve the care and well-being of preterm infants and their families.

Design Parallel-group randomised trial (1.1 allocation; intention-to-treat) with nested diagnostic and cost evaluations (EudraCT 2009-011602-42).

Setting Participants from 14 London hospitals, imaged at a single centre.

Patients 511 infants born before 33 weeks gestation underwent both MRI and ultrasound around term. 255 were randomly allocated (siblings together) to receive only MRI results and 255 only ultrasound from a paediatrician unaware of unallocated results; one withdrew before allocation.

Main outcome measures Maternal anxiety, measured by the State-Trait Anxiety inventory (STAI) assessed in 206/214 mothers receiving MRI and 217/220 receiving ultrasound. Secondary outcomes included: prediction of neurodevelopment, health-related costs and quality of life.

Results After MRI, STAI fell from 36.81 (95% CI 35.18 to 38.44) to 32.77 (95% CI 31.54 to 34.01), 31.87 (95% CI 30.63 to 33.12) and 31.82 (95% CI 30.65 to 33.00) at 14 days, 12 and 20 months, respectively. STAI fell less after ultrasound: from 37.59 (95% CI 36.00 to 39.18) to 33.97 (95% CI 32.78 to 35.17), 33.43 (95% CI 32.22 to 34.63) and 33.63 (95% CI 32.49 to 34.77), p=0.02. There were no differences in health-related quality of life. MRI predicted moderate or severe functional motor impairment at 20 months slightly better than ultrasound (area under the receiver operator characteristic curve (CI) 0.74; 0.66 to 0.83 vs 0.64; 0.56 to 0.72, p=0.01) but cost £315 (CI £295–£336) more per infant.

Conclusions MRI increased costs and provided only modest benefits.

Trial registration ClinicalTrials.gov NCT01049594 https://clinicaltrials.gov/ct2/show/NCT01049594.

EudraCT: EudraCT: 2009-011602-42 (https://www.clinicaltrialsregister.eu/).

  • preterm
  • MRI
  • ultrasound
  • STAI
  • neurodevelopment

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/archdischild-2017-313102

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    Footnotes

    • Contributors ADE, MER and ORA contributed to the study design, data analysis, data interpretation, literature search, figures and writing the manuscript. NK contributed to the study design, data collection, data interpretation and writing the manuscript. NGC contributed to data collection, figures, writing the manuscript. PN, ADE, SF, AC and OE contributed to data collection, data interpretation and writing the manuscript. OO contributed to data interpretation, data analysis, writing the manuscript. PH contributed to data interpretation, data analysis and writing the statistical analysis plan and the manuscript. MH, NH and JW contributed to data collection and approving the manuscript. DA was involved in the study design, data interpretation and writing the manuscript. MAR contributed to the study design, data interpretation and approving the manuscript. SJC contributed to study design, data analysis, data interpretation and approving the manuscript. The ePrime Investigators were: ePrime investigators: Radiographers: J Allsop, M Fox, E Hughes. Child Psychology and Psychiatry: C Nosarti, E Simonoff. MR Imaging: J Hajnal. Database Specialists: A King, N Harper. Follow-up Specialist: A Knight. Statistician: E Judszcak. Recruitment Site Principal Investigators: S Godambe (Queen Charlotte’s and Chelsea Hospital, St Mary’s), M Cruwys (Hillingdon), G Marais, J Chang (Croydon University Hospital), N El Hadi (West Middlesex Hospital), M Cummins, V Chan, R Mathur, (Ealing Hospital), R Nicholl (Northwick Park Hospital), N Kennea (St George’s Hospital), S Yasin (St Helier and Epsom), S Luck, D Lindo (Kingston Hospital), A Kaiser (St Thomas’ Hospital), S Roth (Barnet Hospital), P Reynolds (St Peter’s Hospital).

    • Funding NIHR Programme Grants for Applied Research Programme (RP-PG-0707-10154).

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval Hammersmith and Queen Charlotte’s Research Ethics Committee (09/H0707/98).

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

    • Data sharing statement Requests for Data Sharing should be made to the Chief Investigator.

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