Original ArticleSelective Head Cooling with Mild Systemic Hypothermia after Neonatal Hypoxic-Ischemic Encephalopathy: A Multicenter Randomized Controlled Trial in China
Section snippets
Methods
This study involved the participation of 12 children's hospitals or children's and women's health care centers. The protocol was designed by the neonatologists at Children's Hospital of Fudan University and a consensus was reached by the participating hospitals. Written informed consent was obtained from parents before enrollment. This study was approved by the ethics committee of the Children's Hospital of Fudan University.
Infants were screened for eligibility if they had a gestational age ≥
Results
From May 2003 to August 2005, a total of 256 cases were recruited. Figure 1 (available at www.jpeds.com) shows the trial profile. Twenty-one infants (19 and 2 infants in the selective head cooling and control group) were excluded because the pediatricians in the local hospitals did not follow the scheduled random methods.
Discussion
Hypothermia, whether whole body or selective head cooling, shows great promise on the basis of both animal and human neonatal studies.3, 4, 11, 12, 13, 14, 15 Three RCT trials demonstrated that hypothermia could improve the combined outcome of death and severe neurodevelopmental disability or an increased rate of survival without neurologic abnormality and reduced risks of cerebral palsy at 18 months of age.16, 17, 18 A recently published meta-analysis32 also showed the effectiveness of
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Therapeutic hypothermia for neonatal encephalopathy in developing countries: Current evidence
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2024, Anales de PediatriaHypoxic-Ischemic Encephalopathy: Changing Outcomes Across the Spectrum
2023, Clinics in Perinatology
Supported by grants from Construction of Key Disciplines of 211 Engineering of Ministry of Education of People's Republic of China. The authors declare no conflicts of interest.
Registration number at Clinicaltrials.gov: NCT00890409.
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A list of members of The China Study Group is available at www.jpeds.com (Appendix).