TY - JOUR T1 - Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation JF - Archives of Disease in Childhood - Fetal and Neonatal Edition JO - Arch Dis Child Fetal Neonatal Ed SP - F15 LP - F21 DO - 10.1136/archdischild-2017-313102 VL - 103 IS - 1 AU - A David Edwards AU - Maggie E Redshaw AU - Nigel Kennea AU - Oliver Rivero-Arias AU - Nuria Gonzales-Cinca AU - Phumza Nongena AU - Moegamad Ederies AU - Shona Falconer AU - Andrew Chew AU - Omar Omar AU - Pollyanna Hardy AU - Merryl Elizabeth Harvey AU - Oya Eddama AU - Naomi Hayward AU - Julia Wurie AU - Denis Azzopardi AU - Mary A Rutherford AU - Serena Counsell A2 - , Y1 - 2018/01/01 UR - http://fn.bmj.com/content/103/1/F15.abstract N2 - 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/). ER -