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Randomized Controlled Trial
. 2018 Jan;103(1):F15-F21.
doi: 10.1136/archdischild-2017-313102. Epub 2017 Oct 7.

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

A David Edwards  1 , Maggie E Redshaw  2 , Nigel Kennea  3 , Oliver Rivero-Arias  2 , Nuria Gonzales-Cinca  1 , Phumza Nongena  4 , Moegamad Ederies  4 , Shona Falconer  1 , Andrew Chew  1 , Omar Omar  2 , Pollyanna Hardy  2 , Merryl Elizabeth Harvey  5 , Oya Eddama  2 , Naomi Hayward  4 , Julia Wurie  1 , Denis Azzopardi  1 , Mary A Rutherford  1 , Serena Counsell  1 ; ePrime Investigators
Affiliations
Randomized Controlled Trial

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

A David Edwards et al. Arch Dis Child Fetal Neonatal Ed. 2018 Jan.

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/).

Keywords: MRI; STAI; neurodevelopment; preterm; ultrasound.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials diagram for randomised study and for diagnostic evaluation. GMFCS, gross motor function classification system; STAI, State-Trait Anxiety Inventory.
See this image and copyright information in PMC

References

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