Neonatal ECMO Study of Temperature (NEST)--a randomised controlled trial

Area of Science:

• Neonatal intensive care
• Pediatric critical care medicine
• Cardiorespiratory failure management

Background:

• Neonates with severe cardio-respiratory failure have doubled survival chances with ECMO, but many experience disability.
• The NEST trial investigates if therapeutic hypothermia improves long-term health in neonates requiring ECMO.

Purpose of the Study:

• To determine if cooling neonates to 34°C for 48-72 hours during ECMO improves later health status.
• To compare neurodevelopmental outcomes at 2 years corrected age between cooled and non-cooled ECMO groups.

Main Methods:

• Multi-centre randomized controlled trial in UK ECMO centers.
• Infants randomly assigned to ECMO with cooling (34°C) or standard ECMO (37°C).
• Health status assessed at 2 years corrected age using Bayley Scales of Infant and Toddler Development (Bayley-III).

Main Results:

• Primary analysis compares mean cognitive scores of surviving infants in each group (intention-to-treat).
• Subgroup analyses explore cooling effects based on ECMO type, oxygenation index, aEEG, and diagnosis.
• The study aims to provide a fair representation of average ability, acknowledging limitations of excluding non-survivors.

Conclusions:

• The study will explore the consistency of cooling's effect across different infant subgroups.
• Findings will inform clinical practice regarding the use of therapeutic hypothermia in neonatal ECMO.
• The trial aims to optimize long-term health outcomes for critically ill neonates.