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Assessing the neuro-protective effect of mild cooling in neonates receiving extra-corporeal membrane oxygenation (ECMO)
ISRCTN ISRCTN72635512
DOI 10.1186/ISRCTN72635512
ClinicalTrials.gov identifier
EudraCT number
Public title Assessing the neuro-protective effect of mild cooling in neonates receiving extra-corporeal membrane oxygenation (ECMO)
Scientific title Assessing the neuro-protective effect of mild cooling in neonates receiving extra-corporeal membrane oxygenation (ECMO): a randomised controlled trial
Acronym NEST Study
Serial number at source N/A
Study hypothesis Does cooling neonates requiring extra-corporeal membrane oxygenation (ECMO) to 34°C for the first 48 to 72 hours of their ECMO run result in improved neurodevelopmental outcome at 2 years corrected age?

Please note that as of 11/02/2009 this record was updated to include amended trial dates. The initial trial dates at the time of registration were:
Initial anticipated start date: 01/11/2005
Initial anticipated end date: 30/11/2010

Please note that as of 19/05/10 this record was updated. All updates can be found in the relevant field with the above update date.
Lay summary Not provided at time of registration
Ethics approval Added 11/02/2009: Trent Multi-Centre Research Ethics Committee gave approval on the 9th June 2005 (ref: 05/MRE04/22)
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Fully grown newborn babies requiring help with their breathing and circulation.
Participants - inclusion criteria Babies recruited to the study must be the existing standard criteria for ECMO eligibility.
These include:
1. To be at least 35 weeks gestation
2. To be at least 2000 g birth weight
3. To have no uncontrolled bleeding disorder
4. To have no congenital or acquired central nervous system (CNS) disorder
5. To have undergone no more than 7 consecutive days of high pressure ventilation prior to referral for ECMO
6. To be suffering from a condition which is potentially reversible
7. To have evidence of severe cardio respiratory failure
8. Less than 29 days of age, either sex
Participants - exclusion criteria 1. All neonates referred with diaphragmatic hernia
2. All neonates receiving ECMO for post operative cardiac support

Added 19/05/10:
3. All neonates who have been cooled prior to ECMO
Anticipated start date 03/10/2005
Anticipated end date 31/05/2012
Status of trial Completed
Patient information material Information for females can be found at: http://www.npeu.ox.ac.uk/nest/nest_downloads/NEST_study_information_leaflet_F.pdf Information for males can be found at: http://www.npeu.ox.ac.uk/nest/nest_downloads/NEST_study_information_leaflet_M.pdf
Target number of participants 118
Interventions Babies receiving ECMO will be randomised to standard ECMO or ECMO with mild cooling.

As of 19/05/10 this trial is now in follow-up phase.

As of 11/07/2012 the recruitment and follow-up phases are complete and the data collected are under analysis.
Primary outcome measure(s) Current information as of 19/05/10:
Cognitive score from the Bayley scales of Infant and toddler Development, 3rd edition (Bayley-III) at age of 2 years (24 - 27 months)

Initial information at time of registration:
The Mental Development Index (MDI) of the Bayley scales of the surviving children in each arm of the study at the age of 2 years (24 - 27 months)
Secondary outcome measure(s) Current information as of 19/05/10:
1. Death
2. Neurological optimality score
3. Gross and fine motor score from the Bayley-III
4. Cerebral Palsy
5. Gross motor function classification score (GMFCS)
6. Seizures requiring regular anticonvulsant treatment
7. Visual difficulties not corrected by spectacles
8. Hearing difficulties requiring aids
9. Language: expressive and receptive scores from the Bayley-III
10. Parent Report of Children's Abilities (PARCA-R)
11. Infant Characteristics Questionnaire
12. The Brief Infant-Toddler Social and Emotional Assessment (BITSEA)
13. Measure of growth: height, weight and head circumference
A child will be considered to be functioning within the normal range for age if their results are within the normal range for all Bayley scores and they have a normal neurological examination, normal vision (including with spectacles) and normal hearing (no aids).

Initial information at time of registration:
1. A structured neurological assessment
2. Parent perception of their child’s health at two years of age
3. The Psychomotor Development Index (PDI) from the Bayley scales
4. Visuospatial assessment
5. The Testers rating of child behaviour
Sources of funding British Heart Foundation (BHF) (UK) (ref: SP/04/004)
Trial website http://www.npeu.ox.ac.uk/nest
Publications 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20403176
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24144703
Contact name Prof  David  Field
  Address Professor of Neonatal Medicine
Dept of Health Sciences
University of Leicester
22-28 Princess Road West
  City/town Leicester
  Zip/Postcode LE1 6TP
  Country United Kingdom
  Tel +44 (0)116 258 7707
  Fax +44 (0)116 258 5502
  Email Df63@le.ac.uk
Sponsor University Hospitals of Leicester NHS Trust (UK)
  Address Trust Headquarters
Gwendolin Road
  City/town Leicester
  Zip/Postcode LE5 4QF
  Country United Kingdom
  Tel +44 (0)116 258 4199
  Fax +44 (0)116 285 4487
  Email djr8@le.ac.uk
Date applied 01/08/2005
Last edited 17/01/2014
Date ISRCTN assigned 21/09/2005
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