Original ArticleA Randomized Clinical Trial of Therapeutic Hypothermia Mode during Transport for Neonatal Encephalopathy
Section snippets
Methods
The Institutional Review Board of each of the 9 participating institutions approved the protocol. Informed consent was obtained prior to enrollment. An independent Data Safety Monitoring Committee provided oversight and met via teleconference prior to initiation of the trial and after enrollment of 25, 50, 75 and 100 patients. The Coordinating Center at Stanford University supervised the overall conduct of the trial.
A study initiation meeting was held to review the protocol and manual of
Results
Nine participating neonatal intensive care units recruited subjects between October 1, 2012 and September 27, 2013. The trial was closed when 100 newborns were enrolled. Of 131 infants screened for eligibility, 30 were excluded, and 101 consented and were randomized (Figure 1; available at www.jpeds.com). One hundred patients completed the study; 49 in the control group and 51 in the device group. One patient was consented and randomized to the control arm, however, a decision was subsequently
Discussion
In this randomized clinical trial performed by 9 transport teams in California, we found that newborns cooled in transport using a servo-controlled cooling device had significantly improved temperature control when compared with newborns who were cooled by the current practice of passive and active cooling with ice or gel packs. Servo-regulated cooling provides an opportunity to improve cooling practices for outborn infants. Servo-regulated cooling more quickly and reliably achieves target
References (23)
Hypothermia: a systematic review and meta-analysis of clinical trials
Semin Fetal Neonatal Med
(2010)- et al.
Moderate hypothermia in neonatal encephalopathy: efficacy outcomes
Pediatr Neurol
(2005) - et al.
Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial
Lancet
(2005) - et al.
Moderate hypothermia in neonatal encephalopathy: safety outcomes
Pediatr Neurol
(2005) - et al.
“Therapeutic time window” duration decreases with increasing severity of cerebral hypoxia-ischaemia under normothermia and delayed hypothermia in newborn piglets
Brain Res
(2007) - et al.
Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support
J Biomed Inform
(2009) - et al.
Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy
N Engl J Med
(2005) - et al.
Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial
Arch Pediatr Adolesc Med
(2011) - et al.
Moderate hypothermia to treat perinatal asphyxial encephalopathy
N Engl J Med
(2009) - et al.
Systemic hypothermia after neonatal encephalopathy: outcomes of neo.nEURO.network RCT
Pediatrics
(2010)
Cooling for newborns with hypoxic ischaemic encephalopathy
Cochrane Database Syst Rev
Cited by (59)
Neonatal Transport Safety Metrics and Adverse Event Reporting: A Systematic Review
2023, Air Medical JournalNeonatal Transport
2023, Avery's Diseases of the NewbornNeonatal Encephalopathy
2023, Avery's Diseases of the NewbornBeyond the Clinical Trials: Off-Protocol Therapeutic Hypothermia
2022, Clinics in PerinatologyCitation Excerpt :Clinical manifestations of HIE might not be apparent (or appreciated) immediately after birth, and travel times and transport team constraints could result in failure to evaluate and initiate cooling for infants “in time,” with the suboptimal result of infants not receiving state-of-the-art neuroprotective care. Although the development of cooling systems that can be used during transport, and gradual institution of clinical cooling procedures in more community hospital NICUs have reduced the likelihood of missed opportunities to initiate TH,20 late presentation and recognition of HIE and continued logistic obstacles to timely initiation of treatment perpetuate the desire to understand whether late initiation of treatment is appropriate. In a 2012 report from the Vermont Oxford Network Neonatal Encephalopathy registry, Pfister and colleagues21 reported that more than one-third of infants were not admitted to a NICU until after 6 hours of age.
Proposing a care practice bundle for neonatal encephalopathy during therapeutic hypothermia
2021, Seminars in Fetal and Neonatal Medicine
Supported by the National Institutes of Health (NIH)/National Center for Advancing Translational Sciences (CTSA UL1 TR000093), Lucile Packard Foundation for Children's Health, and the Child Health Research Institute. Inspiration Healthcare (UL1 RR025744), LTD loaned the devices (Tecotherm Neo) to the participating institutions for use in this randomized clinical trial. This research made use of the REDCap (Research Data Capture) database hosted at the Stanford Center for Clinical Informatics. REDCap at Stanford is supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, NIH (UL1 RR025744). V.A. received support from the Ernest and Amelia Gallo Endowed Postdoctoral Fellowship. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The authors declare no conflicts of interest.
Registered with Clinicaltrials.gov: NCT01683383.