Elsevier

The Journal of Pediatrics

Volume 166, Issue 4, April 2015, Pages 856-861.e2
The Journal of Pediatrics

Original Article
A Randomized Clinical Trial of Therapeutic Hypothermia Mode during Transport for Neonatal Encephalopathy

https://doi.org/10.1016/j.jpeds.2014.12.061Get rights and content

Objective

To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice.

Study design

We performed a multicenter, randomized, nonmasked clinical trial in newborns with neonatal encephalopathy cooled during transport to 9 neonatal intensive care units in California. Newborns who met institutional criteria for therapeutic hypothermia were randomly assigned to receive cooling according to usual center practices vs device servo-regulated cooling. The primary outcome was the percentage of temperatures in target range (33°-34°C) during transport. Secondary outcomes included percentage of newborns reaching target temperature any time during transport, time to target temperature, and percentage of newborns in target range 1 hour after cooling initiation.

Results

One hundred newborns were enrolled: 49 to control arm and 51 to device arm. Baseline demographics did not differ with the exception of cord pH. For each subject, the percentage of temperatures in the target range was calculated. Infants cooled using the device had a higher percentage of temperatures in target range compared with control infants (median 73% [IQR 17-88] vs 0% [IQR 0-52], P < .001). More subjects reached target temperature during transport using the servo-regulated device (80% vs 49%, P <.001), and in a shorter time period (44 ± 31 minutes vs 63 ± 37 minutes, P = .04). Device-cooled infants reached target temperature by 1 hour with greater frequency than control infants (71% vs 20%, P < .001).

Conclusions

Cooling using a servo-regulated device provides more predictable temperature management during neonatal transport than does usual care for outborn newborns with 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)

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      Citation 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.

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    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.

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