RT Journal Article
SR Electronic
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
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP fetalneonatal-2017-313102
DO 10.1136/archdischild-2017-313102
A1 A David Edwards
A1 Maggie E Redshaw
A1 Nigel Kennea
A1 Oliver Rivero-Arias
A1 Nuria Gonzales-Cinca
A1 Phumza Nongena
A1 Moegamad Ederies
A1 Shona Falconer
A1 Andrew Chew
A1 Omar Omar
A1 Pollyanna Hardy
A1 Merryl Elizabeth Harvey
A1 Oya Eddama
A1 Naomi Hayward
A1 Julia Wurie
A1 Denis Azzopardi
A1 Mary A Rutherford
A1 Serena Counsell
A1 ,
YR 2017
UL http://fn.bmj.com/content/early/2017/10/07/archdischild-2017-313102.abstract
AB 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/).