Neo.nEuro.network - Induced systemic hypothermia in asphyxiated newborn infants: a randomized, controlled multicenter study

Study aim and design

Newborn infants with a gestational age of > 36 weeks , asphyxiated at birth, who show evidence of encephalopathy and who have abnormal EEG within 6 hrs of postnatal age, have been randomized to hypothermia or to normothermia. Hypothermia (target rectal tem­perature 33.5°C) was induced by using a cooling matters, perfused with water. Hypother­mia was maintained for 72 hours. Infants in both groups received morphine at a seda­tive and analgesic dosage.

Study group

Participants in Germany and other European Countries within the framework of the ”neo-nEuro-network” (abbreviated n.n.n), an non-juridal association of neonatologists interested in neurological and neuro-intensive care investigations.

Scientific Committee of the nnn Hypothermia Study: 

Simbruner G, Division of Neonatology, Medical University Innsbruck (principal investigator)

Blennow M, Huddige Hospital , Huddige, Sweden,
Gaus W, Univ Ulm, Ulm, Germany 
Greisen G, Univ Copenhagen, Copenhagen, Denmark 
Obladen M, Charite, Humboldt Univ, Berlin, Germany 
Pohlandt F, Univ Ulm, Ulm, Germany 
Simbruner G, LMU, Munich,Germany 
Thoresen M, Univ Bristol, Bristol , UK 
Zupan V, Univ Paris, Paris, France

Acknowledgement

We thank the principal investigator Peter D Gluckman, Auckland, New Zealand of the Olympic Medical Brain Cooling Trial and Olympic Medical for providing a copy of that protocol. Inclusion and exclusion criteria and the primary endpoint were identical in the two protocols. The brain cooling trial used a cooling cap and a target body temperature of 34.5°C whereas we used systemic cooling to 33.5°C and all patients received mor­phine for pain and sedation. We also thank Professors Azzopardi D and Edwards DA for providing insight into their study protocol.