Systemic Hypothermia After Neonatal Encephalopathy: Outcomes of neo.nEURO.network RCT.
Summary of "Systemic Hypothermia After Neonatal Encephalopathy: Outcomes of neo.nEURO.network RCT."
Objective: Mild hypothermia after perinatal hypoxic-ischemic encephalopathy (HIE) reduces neurologic sequelae without significant adverse effects, but studies are needed to determine the most-efficacious methods. Methods: In the neo.nEURO.network trial, term neonates with clinical and electrophysiological evidence of HIE were assigned randomly to either a control group, with a rectal temperature of 37°C (range: 36.5-37.5°C), or a hypothermia group, cooled and maintained at a rectal temperature of 33.5°C (range: 33-34°C) with a cooling blanket for 72 hours, followed by slow rewarming. All infants received morphine (0.1 mg/kg) every 4 hours or an equivalent dose of fentanyl. Neurodevelopmental outcomes were assessed at the age of 18 to 21 months. The primary outcome was death or severe disability. Results: A total of 129 newborn infants were enrolled, and 111 infants were evaluated at 18 to 21 months (53 in the hypothermia group and 58 in the normothermia group). The rates of death or severe disability were 51% in the hypothermia group and 83% in the normothermia group (P = .001; odds ratio: 0.21 [95% confidence interval [CI]: 0.09-0.54]; number needed to treat: 4 [95%
CI:
3-9]). Hypothermia also had a statistically significant protective effect in the group with severe HIE (n = 77; P = .005; odds ratio: 0.17 [95%
CI:
0.05-0.57]). Rates of adverse events during the intervention were similar in the 2 groups except for fewer clinical seizures in the hypothermia group. Conclusion: Systemic hypothermia in the neo.nEURO.network trial showed a strong neuroprotective effect and was effective in the severe HIE group.
Affiliation
Division of Pediatrics IV, Department of Neonatology and Neuropediatrics, Medical University of Innsbruck, Innsbruck, Austria;
Journal Details
This article was published in the following journal.
Name: Pediatrics
ISSN: 1098-4275
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/20855387
- DOI: http://dx.doi.org/10.1542/peds.2009-2441
Medical and Biotech [MESH] Definitions
Systemic Inflammatory Response Syndrome
A systemic inflammatory response to a variety of clinical insults, characterized by two or more of the following conditions: (1) fever >38 degrees C or HYPOTHERMIA <36 degrees C; (2) TACHYCARDIA >90 beat/minute; (3) tachypnea >24 breaths/minute; (4) LEUKOCYTOSIS >12,000 cells/cubic mm or 10% immature forms. While usually related to infection, SIRS can also be associated with noninfectious insults such as TRAUMA; BURNS; or PANCREATITIS. If infection is involved, a patient with SIRS is said to have SEPSIS.
Hypothermia, Induced
Abnormally low BODY TEMPERATURE that is intentionally induced in warm-blooded animals by artificial means. In humans, mild or moderate hypothermia has been used to reduce tissue damages, particularly after cardiac or spinal cord injuries and during subsequent surgeries.
Jaundice, Neonatal
Yellow discoloration of the SKIN; MUCOUS MEMBRANE; and SCLERA in the NEWBORN. It is a sign of NEONATAL HYPERBILIRUBINEMIA. Most cases are transient self-limiting (PHYSIOLOGICAL NEONATAL JAUNDICE) occurring in the first week of life, but some can be a sign of pathological disorders, particularly LIVER DISEASES.
Hyperbilirubinemia, Neonatal
Accumulation of BILIRUBIN, a breakdown product of HEME PROTEINS, in the BLOOD during the first weeks of life. This may lead to NEONATAL JAUNDICE. The excess bilirubin may exist in the unconjugated (indirect) or the conjugated (direct) form. The condition may be self-limiting (PHYSIOLOGICAL NEONATAL JAUNDICE) or pathological with toxic levels of bilirubin.
Thanatophoric Dysplasia
A severe form of neonatal dwarfism with very short limbs. All cases have died at birth or later in the neonatal period.
PubMed Articles
Childhood Outcomes after Hypothermia for Neonatal Encephalopathy.
Background We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy showing a significant reduction in the rate of death or mod...
The Efficacy of Hypothermia in Hypoxic-Ischemic Encephalopathy at 18 Mo or More.
OBJECTIVE: To evaluate the efficacy of hypothermia in the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates at 18 mo of age or more. Also to examine whether the sev...
Therapeutic Hypothermia for Neonatal Encephalopathy.
OPINION STATEMENT: Neonatal Hypoxic-ischemic encephalopathy in full term infants has been associated with a high risk for morbidity and mortality. The patho-physiology of brain injury following hypoxi...
Hand-touch Method for Detection of Neonatal Hypothermia in Nepal.
Neonatal hypothermia is the fourth leading causes of neonatal death in Nepal. Thus, it is the caregivers' responsibility to identify the hypothermia by using valid and less time consuming method like...
Hypercalcemia Due to Subcutaneous Fat Necrosis in a Newborn After Total Body Cooling.
Subcutaneous fat necrosis is an inflammatory disorder of adipose tissue. Although patients need long-term follow-up to prevent hypercalcemia, the prognosis is generally favorable. We herein presen...
Clinical Trials
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants...
Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy
Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths globall...
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).
Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
This is a randomised controlled trial in newborn infants with perinatal asphyxial encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve cerebral metaboli...
Study of Cerebrolysin for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic en...
