Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation. Issue 1 (7th October 2017)

• Record Type: Journal Article
• Authors: Edwards, A David; Redshaw, Maggie E; Kennea, Nigel; Rivero-Arias, Oliver; Gonzales-Cinca, Nuria; Nongena, Phumza; Ederies, Moegamad; Falconer, Shona; Chew, Andrew; Omar, Omar; Hardy, Pollyanna; Harvey, Merryl Elizabeth; Eddama, Oya; Hayward, Naomi; Wurie, Julia; Azzopardi, Denis; Rutherford, Mary A; Counsell, Serena
• Is Part Of: Archives of disease in childhood. Volume 103:Issue 1(2018)
• Page Start: F15
• Page End: F21
• Publication Date: 2017-10-07
• Subjects: preterm -- MRI -- ultrasound -- STAI -- neurodevelopment; Infants -- Diseases -- Periodicals; Newborn infants -- Diseases -- Periodicals; Fetus -- Diseases -- Periodicals; 618.920105
• DOI: 10.1136/archdischild-2017-313102
• Languages: English
• ISSNs: 1359-2998

Abstract

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/ ).