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 |
| Secondary identifying numbers | N/A |
- 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
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 |
|---|---|
| Df63@le.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 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 |
| 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 | 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 measures | 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 |
| Overall study start date | 03/10/2005 |
| Completion date | 31/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Professor of Neonatal Medicine
Leicester
LE1 6TP
United Kingdom
LE1 6TP
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust Headquarters
Gwendolin Road
Leicester
LE5 4QF
England
United Kingdom
| Phone | +44 (0)116 258 4199 |
|---|---|
| djr8@le.ac.uk | |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Charity
British Heart Foundation (BHF) (UK) (ref: SP/04/004)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/04/2010 | Yes | No | |
| Results article | results | 01/11/2013 | Yes | No |
