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Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation
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Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation
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Journal Article
Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation
2018
Overview
BackgroundWe tested the hypothesis that routine MRI would improve the care and well-being of preterm infants and their families.DesignParallel-group randomised trial (1.1 allocation; intention-to-treat) with nested diagnostic and cost evaluations (EudraCT 2009-011602-42).SettingParticipants from 14 London hospitals, imaged at a single centre.Patients511 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 measuresMaternal 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.ResultsAfter 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.ConclusionsMRI increased costs and provided only modest benefits.Trial registrationClinicalTrials.gov NCT01049594 https://clinicaltrials.gov/ct2/show/NCT01049594. EudraCT: EudraCT: 2009-011602-42 (https://www.clinicaltrialsregister.eu/).
Publisher
BMJ Publishing Group LTD,BMJ Publishing Group
Subject
/ Age
/ Anxiety
/ Babies
/ Brain - growth & development
/ Costs
/ Female
/ Humans
/ Infant, Premature - physiology
/ Infants
/ Magnetic Resonance Imaging - economics
/ Magnetic Resonance Imaging - methods
/ Magnetic Resonance Imaging - psychology
/ Male
/ Maternal Behavior - psychology
/ Mothers
/ Neurologic Examination - methods
/ Neurologic Examination - statistics & numerical data
/ Original
