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Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluatio

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A David Edwards, Maggie E Redshaw, Nigel Kennea, Oliver Rivero-Arias, Nuria Gonzales-Cinca, Phumza Nongena, Moegamad Ederies, Shona Falconer, Andrew Chew, Omar Omar, Pollyanna Hardy, Merryl Elizabeth Harvey, Oya Eddama, Naomi Hayward, Julia Wurie, Denis Azzopardi, Mary A Rutherford, Serena Counsell, ePrime Investigators.

Original languageEnglish
Pages (from-to)F15-F21
JournalADC Fetal & Neonatal
Volume103
Issue number1
Early online date7 Oct 2017
DOIs
Accepted/In press13 Aug 2017
E-pub ahead of print7 Oct 2017
PublishedJan 2018

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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/).

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