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

A David Edwards; Maggie E Redshaw; Nigel Kennea; Oliver Rivero-Arias; Nuria Gonzales-Cinca; Phumza Nongena; Moegamad Ederies; Shona Falconer; Andrew Chew; Omar Omar; Pollyanna Hardy; Merryl Elizabeth Harvey; Oya Eddama; Naomi Hayward; Julia Wurie; Denis Azzopardi; Mary A Rutherford; Serena Counsell; ePrime Investigators

doi:10.1136/archdischild-2017-313102

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

A David Edwards, Maggie E Redshaw, Nigel Kennea, Oliver Rivero-Arias, Nuria Gonzales-Cinca, Phumza Nongena, Moegamad Ederies, Shona Falconer, Andrew Chew, Omar Omar, Pollyanna Hardy, Merryl Elizabeth Harvey, Oya Eddama, Naomi Hayward, Julia Wurie, Denis Azzopardi, Mary A Rutherford, Serena Counsell, ePrime Investigators

Birmingham Clinical Trials Unit

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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/).

Original language	English
Journal	Archives of disease in childhood. Fetal and neonatal edition
Early online date	7 Oct 2017
DOIs	https://doi.org/10.1136/archdischild-2017-313102
Publication status	E-pub ahead of print - 7 Oct 2017

Keywords

Journal Article

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Edwards, A. D., Redshaw, M. E., Kennea, N., Rivero-Arias, O., Gonzales-Cinca, N., Nongena, P., Ederies, M., Falconer, S., Chew, A., Omar, O., Hardy, P., Harvey, M. E., Eddama, O., Hayward, N., Wurie, J., Azzopardi, D., Rutherford, M. A., Counsell, S., & ePrime Investigators (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. Advance online publication. https://doi.org/10.1136/archdischild-2017-313102

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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/).",

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author = "Edwards, {A David} and Redshaw, {Maggie E} and Nigel Kennea and Oliver Rivero-Arias and Nuria Gonzales-Cinca and Phumza Nongena and Moegamad Ederies and Shona Falconer and Andrew Chew and Omar Omar and Pollyanna Hardy and Harvey, {Merryl Elizabeth} and Oya Eddama and Naomi Hayward and Julia Wurie and Denis Azzopardi and Rutherford, {Mary A} and Serena Counsell and {ePrime Investigators}",

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year = "2017",

month = oct,

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doi = "10.1136/archdischild-2017-313102",

language = "English",

journal = "Archives of disease in childhood. Fetal and neonatal edition",

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Edwards, AD, Redshaw, ME, Kennea, N, Rivero-Arias, O, Gonzales-Cinca, N, Nongena, P, Ederies, M, Falconer, S, Chew, A, Omar, O , Hardy, P, Harvey, ME, Eddama, O, Hayward, N, Wurie, J, Azzopardi, D, Rutherford, MA, Counsell, S & ePrime Investigators 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. https://doi.org/10.1136/archdischild-2017-313102

TY - JOUR

T1 - Effect of MRI on preterm infants and their families

T2 - a randomised trial with nested diagnostic and economic evaluation

AU - Edwards, A David

AU - Redshaw, Maggie E

AU - Kennea, Nigel

AU - Rivero-Arias, Oliver

AU - Gonzales-Cinca, Nuria

AU - Nongena, Phumza

AU - Ederies, Moegamad

AU - Falconer, Shona

AU - Chew, Andrew

AU - Omar, Omar

AU - Hardy, Pollyanna

AU - Harvey, Merryl Elizabeth

AU - Eddama, Oya

AU - Hayward, Naomi

AU - Wurie, Julia

AU - Azzopardi, Denis

AU - Rutherford, Mary A

AU - Counsell, Serena

AU - ePrime Investigators

PY - 2017/10/7

Y1 - 2017/10/7

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/).

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/).

KW - Journal Article

U2 - 10.1136/archdischild-2017-313102

DO - 10.1136/archdischild-2017-313102

M3 - Article

C2 - 28988160

SN - 1359-2998

JO - Archives of disease in childhood. Fetal and neonatal edition

JF - Archives of disease in childhood. Fetal and neonatal edition

ER -

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

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