TY - JOUR
T1 - Moderate hypothermia in neonatal encephalopathy
T2 - Safety outcomes
AU - Eicher, Dorothea J.
AU - Wagner, Carol L.
AU - Katikaneni, Lakshmi P.
AU - Hulsey, Thomas C.
AU - Bass, W. Thomas
AU - Kaufman, David A.
AU - Horgan, Michael J.
AU - Languani, Sheila
AU - Bhatia, Jatinder J
AU - Givelichian, Lawrence M.
AU - Sankaran, Koravangatta
AU - Yager, Jerome Y.
N1 - Funding Information:
This trial was funded by the National Institutes of Neurologic Disorders and Stroke, R01 NS38602.
PY - 2005/1
Y1 - 2005/1
N2 - Hypoxic-ischemic injury may cause multisystem organ damage with significant aberrations in clotting, renal, and cardiac functions. Systemic hypothermia may aggravate these medical conditions, such as bradycardia and increased clotting times, and very little safety data in neonatal hypoxic-ischemic injury is available. This study reports a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event. The best outcome measures of safety were determined, comparing rates of adverse events between normothermia and hypothermia groups. A total of 32 hypothermia and 33 normothermia neonates were enrolled in seven centers. Adverse events and serious adverse effects were collected by the study team during the hospital admission, monitored by an independent study monitor, and reported to Institutional Review Boards and the Data and Safety Monitoring Committee. The following adverse events were observed significantly more commonly in the hypothermia group: more frequent bradycardia and lower heart rates during the period of hypothermia, longer dependence on pressors, higher prothrombin times, and lower platelet counts with more patients requiring plasma and platelet transfusions. Seizures as an adverse event were more common in the hypothermia group. These observed side effects of 48 hours of moderate systemic hypothermia were of mild to moderate severity and manageable with minor interventions.
AB - Hypoxic-ischemic injury may cause multisystem organ damage with significant aberrations in clotting, renal, and cardiac functions. Systemic hypothermia may aggravate these medical conditions, such as bradycardia and increased clotting times, and very little safety data in neonatal hypoxic-ischemic injury is available. This study reports a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event. The best outcome measures of safety were determined, comparing rates of adverse events between normothermia and hypothermia groups. A total of 32 hypothermia and 33 normothermia neonates were enrolled in seven centers. Adverse events and serious adverse effects were collected by the study team during the hospital admission, monitored by an independent study monitor, and reported to Institutional Review Boards and the Data and Safety Monitoring Committee. The following adverse events were observed significantly more commonly in the hypothermia group: more frequent bradycardia and lower heart rates during the period of hypothermia, longer dependence on pressors, higher prothrombin times, and lower platelet counts with more patients requiring plasma and platelet transfusions. Seizures as an adverse event were more common in the hypothermia group. These observed side effects of 48 hours of moderate systemic hypothermia were of mild to moderate severity and manageable with minor interventions.
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UR - http://www.scopus.com/inward/citedby.url?scp=19944380119&partnerID=8YFLogxK
U2 - 10.1016/j.pediatrneurol.2004.06.015
DO - 10.1016/j.pediatrneurol.2004.06.015
M3 - Article
C2 - 15607599
AN - SCOPUS:19944380119
SN - 0887-8994
VL - 32
SP - 18
EP - 24
JO - Pediatric Neurology
JF - Pediatric Neurology
IS - 1
ER -