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

Edwards, David A. and Redshaw, Maggie E. and Kennea, Nigel and Rivero-Arias, Oliver and Gonzalez-Cinca, Nuria and Nongena, Phumza and Ederies, Moegamad and Falconer, Shona and Chew, Andrew and Omar, Omar and Hardy, Pollyanna and Harvey, M.E. and Eddama, Oya and Hayward, Naomi and Wurie, Julia and Azzopardi, Denis and Rutherford, Mary A and Counsell, Serena (2017) Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation. Archives of Disease in Childhood - Fetal and Neonatal Edition. pp. 1-7. ISSN 1468-2052

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Abstract

ackground 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.

Item Type: Article
Identification Number: https://doi.org/10.1136/archdischild-2017-313102
Dates:
DateEvent
7 October 2017Published
13 August 2017Accepted
Subjects: CAH01 - medicine and dentistry > CAH01-01 - medicine and dentistry > CAH01-01-01 - medical sciences (non-specific)
CAH02 - subjects allied to medicine > CAH02-04 - nursing and midwifery > CAH02-04-01 - nursing (non-specific)
Divisions: Faculty of Health, Education and Life Sciences > Centre for Social Care, Health and Related Research (C-SHARR)
Depositing User: Merryl Harvey
Date Deposited: 12 Oct 2017 21:40
Last Modified: 03 Mar 2022 17:15
URI: https://www.open-access.bcu.ac.uk/id/eprint/5215

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