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

Completed

• Conditions: Fully grown newborn babies requiring help with their breathing and circulation.; Neonatal Diseases; Respiratory

• Registration Number: ISRCTN72635512
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 118

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current information as of 19/05/10:<br>Cognitive score from the Bayley scales of Infant and toddler Development, 3rd edition (Bayley-III) at age of 2 years (24 - 27 months)<br><br>Initial information at time of registration:<br>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)