Fully grown newborn babies requiring help with their breathing and circulation. Neonatal Diseases Respiratory
Conditions
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 co
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed