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Neonatal ECMO Study of Temperature.

Trial started: 2006  Trial ended: 2012

Summary

Objectives

To determine whether mild therapeutic hypothermia during extracorporeal membrane oxygenation (ECMO) improves neurodevelopmental outcomes in newborn infants.

Methods

A UK randomised controlled trial involving 111 newborn infants receiving ECMO. Infants were randomised to receive either ECMO with cooling to 34°C for the first 48–72 hours or standard ECMO at 37°C. Neurodevelopmental outcomes were assessed at 2 years of age.

Outcome measures

Primary outcome: Cognitive composite score on the Bayley Scales of Infant and Toddler Development, Third Edition, at 2 years of age.

Secondary outcomes included death, neonatal morbidity and other neurodevelopmental and behavioural outcomes at 2 years.

Results

A total of 111 infants were enrolled, of whom 14 died before 2 years of age. Mortality was 16% among infants receiving ECMO with cooling compared with 9% among those receiving standard ECMO. At 2 years, the mean cognitive score was 88.0 (SD 16.2) in 45 assessed children who had received ECMO with cooling and 90.6 (SD 13.1) in 48 who had received standard ECMO (mean difference ?2.6, 95% confidence interval ?8.7 to 3.4). There were no significant differences between the groups in the secondary outcomes, although most favoured standard ECMO without cooling.

Conclusions

Mild hypothermia during the first 48–72 hours of ECMO did not improve outcomes in newborn infants up to 2 years of age.


Summary based on: Field D, Juszczak E, Linsell L, et al. Neonatal ECMO study of temperature (NEST): a randomized controlled trial. Pediatrics. 2013;132(5):e1247–e1256. https://doi.org/10.1542/peds.2013-1754.

Show Publications
  • Field D, Juszczak E, Linsell L, Azzopardi D, Cowan F, Marlow N, Edwards D. Neonatal ECMO study of temperature (NEST): a randomized controlled trial. Pediatrics. 2013;132(5):e1247-56.
    http://www.ncbi.nlm.nih.gov/pubmed/24144703
Published Protocol
  • Field DJ, Firmin R, Azzopardi DV, Cowan F, Juszczak E, Brocklehurst P, et al. Neonatal ECMO study of temperature (NEST) - a randomised controlled trial. BMC Pediatr. [Protocol] 2010;10:24.
    http://www.biomedcentral.com/1471-2431/10/24/
Show Plain Language Summary of Results

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Name
NPEU Clinical Trials Unit
Address
National Perinatal Epidemiology Unit (NPEU)
Nuffield Department of Population Health
University of Oxford
Old Road Campus

Oxford
OX3 7LF
Email
ctu@npeu.ox.ac.uk
Tel
01865 289700