Assessing the neuro-protective effect of mild cooling in neonates receiving extra-corporeal membrane oxygenation (ECMO)

ISRCTN	ISRCTN72635512
DOI	https://doi.org/10.1186/ISRCTN72635512
Protocol serial number	N/A
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	British Heart Foundation (BHF) (UK) (ref: SP/04/004)

Submission date: 01/08/2005
Registration date: 21/09/2005
Last edited: 17/01/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Field
Scientific

Professor of Neonatal Medicine
Dept of Health Sciences
University of Leicester
22-28 Princess Road West
Leicester
LE1 6TP
United Kingdom

Phone	+44 (0)116 258 7707
Email	Df63@le.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Assessing the neuro-protective effect of mild cooling in neonates receiving extra-corporeal membrane oxygenation (ECMO): a randomised controlled trial
Study acronym	NEST Study
Study objectives	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.
Ethics approval(s)	Added 11/02/2009: Trent Multi-Centre Research Ethics Committee gave approval on the 9th June 2005 (ref: 05/MRE04/22)
Health condition(s) or problem(s) studied	Fully grown newborn babies requiring help with their breathing and circulation.
Intervention	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.
Intervention type	Other
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)
Key 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 childs 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
Completion date	31/05/2012

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	118
Key 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
Key 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
Date of first enrolment	03/10/2005
Date of final enrolment	31/05/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Professor of Neonatal Medicine

Leicester
LE1 6TP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2013		Yes	No
Protocol article	protocol	19/04/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes