Effect of MRI on preterm infants and their families

a randomised trial with nested diagnostic and economic evaluation

ePrime Investigators

Research output: Contribution to journalArticle

21 Citations (Scopus)

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 languageEnglish
Pages (from-to)F15-F21
JournalArchives of disease in childhood. Fetal and neonatal edition
Volume103
Issue number1
DOIs
Publication statusPublished - 1 Jan 2018
Externally publishedYes

Fingerprint

Premature Infants
Cost-Benefit Analysis
Anxiety
Costs and Cost Analysis
Equipment and Supplies
Mothers
Quality of Life
Health Care Costs
Siblings
Pregnancy

Keywords

  • MRI
  • neurodevelopment
  • preterm
  • STAI
  • ultrasound

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynaecology

Cite this

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

In: Archives of disease in childhood. Fetal and neonatal edition, Vol. 103, No. 1, 01.01.2018, p. F15-F21.

Research output: Contribution to journalArticle

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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/).",
keywords = "MRI, neurodevelopment, preterm, STAI, ultrasound",
author = "{ePrime Investigators} and 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",
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T1 - Effect of MRI on preterm infants and their families

T2 - a randomised trial with nested diagnostic and economic evaluation

AU - ePrime Investigators

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

PY - 2018/1/1

Y1 - 2018/1/1

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 - MRI

KW - neurodevelopment

KW - preterm

KW - STAI

KW - ultrasound

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U2 - 10.1136/archdischild-2017-313102

DO - 10.1136/archdischild-2017-313102

M3 - Article

VL - 103

SP - F15-F21

JO - Archives of Disease in Childhood: Fetal and Neonatal Edition

JF - Archives of Disease in Childhood: Fetal and Neonatal Edition

SN - 1359-2998

IS - 1

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