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Keywords 0.89, p < 0.0005). The pad plastic covering absorbed 13% of
Phototherapy · Neonatal jaundice · Temperature · blue light from fibres. In the clinical study, the warmest pad
Fibreoptic technology temperature during phototherapy was 38.9 ° C. Axillary tem-
perature increased by a mean (95% CI) of 0.3 ° C (0.1–0.5), p <
0.019, and exceeded 37.5 ° C in 4 babies. Conclusions: LED
Abstract fibreoptic phototherapy pads are heated by high-intensity
Background: Surface temperatures of fibreoptic photother- blue light. The thermal environment and temperature of ba-
apy pads using a high intensity blue light-emitting diode bies should be monitored closely during LED fibreoptic pho-
(LED) light source have not been studied. Objectives: The totherapy. A temperature probe placed between the skin
aim of this study was to measure the temperature of LED fi- and the pad will not accurately reflect the core temperature
breoptic phototherapy pads during phototherapy in a during fibreoptic phototherapy. © 2017 S. Karger AG, Basel
bench-top study, and to determine temperature effects on
babies during phototherapy. Methods: A commercially
available LED fibreoptic phototherapy system was tested. In
a bench-top setting, pad surface temperatures were mea- Introduction
sured before, during and after a 12-h period of phototherapy
(10 different LED light box-pad combinations). A prospec- Light-emitting diode (LED) fibreoptic phototherapy is
tive, cohort study of well babies at >34 weeks’ gestation re- commonly used in the treatment of neonatal hyperbiliru-
ceiving phototherapy was then conducted to determine binaemia. LED fibreoptic systems emit more intense nar-
changes in pad and body temperatures during a 90-min row bandwidth blue light when compared to fibreoptics
phototherapy period. Results: In the bench-top study, the using a halogen light source [1]. Fibreoptic phototherapy
mean (95% CI) pad temperature was 21.8 ° C (21.5–22.1) be- systems in general are advantageous in that they allow
fore lights, 27.0 ° C (26.5–27.5) after 12 h of lights, and 22.1 ° C
(21.9–22.4) 8 h after turning off the lights (F = 366.1, p <
0.0005). The magnitude of change in pad temperature with Dr. P.L. Ng, Dr. T. Carlisle and Dr. S.A. Morris are joint first authors hav-
phototherapy was linearly correlated with irradiance (r = ing made equal contributions to the study and manuscript.
132.239.1.231 - 4/28/2017 7:53:40 AM
Univ. of California San Diego
E-Mail karger@karger.com
Bedford Park, SA 5042 (Australia)
www.karger.com/neo
E-Mail scott.morris @ sa.gov.au
close contact between babies and mothers without inter- infant phototherapy, and a small 15 × 30 cm pad designed for pre-
rupting phototherapy [2]. Halogen fibreoptic systems term infant phototherapy. Both pads have plastic optic fibres wo-
ven into a mesh and a clear plastic polymer covering the optic fibres
have been studied and shown to be effective at reducing (Tecoflex Polymer, Lubrizol Corp, Cleveland, OH, USA). Micro-
bilirubin levels [3]. Fibreoptic systems are frequently used bends created in the optic fibres during the manufacture of the mesh
in combination with overhead lights to maximise the rate deflect light through the fibre cladding and result in light emission
of fall of plasma bilirubin [4]. [7]. Bilisoft Product Information states that spectral irradiance is 49
A perceived advantage of LED fibreoptic photothera- μW/cm2/nm ± 25% for the large pad, and 70 μW/cm2/nm ± 25% for
the small pad when measured at the plastic surface [6].
py over halogen light sources is the delivery of more in-
tense blue light without heating [5–7]. Published data on Temperature Measurement
halogen fibreoptic pads have shown a maximum pad sur- Temperature measurements in bench-top and clinical studies
face temperature of 23 ° C in bench-top studies [5, 8]. We
used thermistor probes (Fisher and Paykel, “Sure-Sense” part
performed a systematic literature search and found no #NC020-01, Fisher and Paykel Healthcare, Auckland, New Zea-
land) secured with a hydrogel adhesive cover with a foil backing
published surface temperature evaluations of LED fibre- (Dräger Thermopads, MX11002, Dräger Medical GmbH, Lübeck,
optic phototherapy pads. Product information for a wide- Germany). Temperature data were collected continuously every
ly used LED fibreoptic phototherapy pad device (BiliSoft, second through the connection of sensors to a datalogger (Omega
GE Healthcare, Aurora, OH, USA) and for the plastic fi- Model OM-DAQPRO-5300, Omega Engineering, Stamford, CT,
breoptic components of this device (Lumitex Medical USA), and analysed as corrected temperatures based on calibra-
tion of the probe and datalogger with a reference electronic ther-
Devices, Strongsville, OH, USA) do not suggest that the mometer (Fluke model 1523, Fluke Corporation, Everett, WA,
pads are heated during phototherapy [6, 7]. However, we USA) having a traceable uncertainty of 0.02 ° C. All sensors were
have noted babies sweating and phototherapy pads get- accurate to <0.1 ° C over a temperature 21–38 ° C.
system has two pad sizes, a large 25 × 30 cm pad designed for term hyperbilirubinaemia or without hyperbilirubinaemia were eligi-
132.239.1.231 - 4/28/2017 7:53:40 AM
Univ. of California San Diego
37.0 26
Temperature, °C
Temperature, °C
25
36.5
24
36.0 23
22
Pad
35.5 Back
Axilla 21
35.0
60 150 210 Before lights Lights on Lights off
on for 12 h for 8 h
Time, min
Study period
Fig. 1. Graph from one study baby illustrating the study protocol. Fig. 2. Change in the temperature of LED fibreoptic phototherapy
For each baby, the temperature recorded for a given phase was the pads when lights are switched on and off. Pad temperature after
average of the last 10 min of that phase. 12 h of phototherapy lights-on was statistically different to pre and
post temperatures for both large and small pads (* p < 0.0005 com-
pared to baseline).
ble. Babies nursed in an incubator where this was turned off and Statistical Methods
at 25–27 ° C were included. Babies who were unwell or with un-
All statistical analyses used IBM SPSS software version 22 (IBM
stable temperatures were excluded from study entry. Withdrawal Corp, Chicago, IL, USA), or Stata version 13.0 (StataCorp, College
of babies occurred at parental request if the baby was unable to Station, TX, USA). An alpha level of 0.05 was used for all analyses.
complete the study protocol due to needing a feed. For the bench-top study, changes in pad temperature between the
Babies were nursed undressed on their back with skin in direct three study periods were analysed using repeated measures analy-
contact with a synthetic material pad cover, with a sheet and a sis of variance, with the study period as the independent variable
light-weight synthetic blanket, and face and head exposed. Tem- and temperature as the dependent variable. A Bonferroni correc-
perature probes were placed in the axilla, in contact with the pad tion was used for post hoc pairwise comparisons. Changes in tem-
and in contact with the skin of the back. The hydrogel adhesive perature from baseline following 12 h of phototherapy were com-
probe cover provided partial isolation of back and pad surface tem- pared between large and small pads using an independent samples
perature measurements. The study protocol is illustrated by data t test. Bivariate correlation was used to determine the association
from one baby shown in Figure 1. Study phase 1 comprised 60 min between change in the temperature and photo-irradiance.
with the phototherapy light off, to allow back and axilla tempera- For the clinical study, clinical characteristics were analysed us-
tures to stabilise. The phototherapy lights were then turned on for ing an independent samples t test or Fisher’s exact test where ap-
90 min (phase 2), followed by a 60-min period where lights were propriate. Absolute temperatures and changes in temperature
turned off (phase 3). The total time period for the study (210 min) were modelled using ordinary least squares regression. Study
was based on the practical constraints of timing of feeds and nappy phase, treatment arm and probe location were included as covari-
changes, both of which require handling and consequently disturb ates. The models were used to calculate adjusted linear predictions
temperature measurement. No baby received overhead photo- for each covariate combination. Post-estimation Wald tests were
therapy. performed to examine pairwise differences between adjusted lin-
A control group of babies was studied to determine the effect ear predictions for different covariate combinations.
of babies’ skin temperature on the pad temperature. This group
was managed in exactly the same way as the study babies with the
exception that the lights were not turned on over the study period. Results
At the conclusion of the study, temperature data for each baby
were graphed as in Figure 1, and each graph was reviewed by the Bench-Top Study
authors. Babies were excluded from the final analysis if the data Pad temperature data for the bench-top study are
from study phases 2 or 3 were uninterpretable due to artefact. For
each study period, the final 10 min of temperature data for each shown in Figure 2. The mean (95% CI) pad temperature
baby were averaged to give a single temperature representative of was 21.8 ° C (21.5–22.1) before lights, 27.0 ° C (26.5–27.5)
5.5 38
5.0
Temperature, °C
37
4.5 36
4.0 35
34
3.5
60 80 100 120 140
33
Irradiance, μW/cm2/nm
1 2 3 1 2 3 1 2 3
Fig. 3. Relationship between irradiance of individual LED fibreop- a Study phase
tic phototherapy pads and increase in pad temperature after 12 h
of phototherapy lights-on. Pad Back Axilla
39
38
ing off lights (F = 366.1, p < 0.0005). Pad temperature was
Temperature, °C
higher after 12 h of lights being on compared to either pre 37
or post light periods for large and small pads (p < 0.0005). 36
The mean (95% CI) increase in temperature was greater
for small pads than large pads, 5.9 ° C (5.7–6.1) versus 35
4.5 ° C (4.0–4.9), p < 0.0005. The mean (95% CI) irradi-
34
ance in the middle of the pad was higher for the small
pads at 120.9 μW/cm2/nm (107.9–133.9) vs. 70.8 (61.4– 33
80.3) for large pads; p < 0.0005. The magnitude of change
in pad temperature was linearly correlated with irradi- 1 2 3 1 2 3 1 2 3
b Study phase
ance in the middle of the pad (r = 0.89, p < 0.0005), as
shown in Figure 3. A mean of approximately 12.9% of
blue light emitted from exposed optic fibres was absorbed Fig. 4. a Pad, back and axillary temperatures in babies receiving
by the plastic cover. Room temperature was constant dur- phototherapy over the three study phases (n = 29). Boxes are the
ing the studies, with a mean (range) of 21.3 ° C (20.3–22.4).
25th and 75th percentiles with the median line shown, and whis-
kers the 5th and 95th percentile. All data including outlying data
are shown, and were included in analysis. Phase 1 is a 60-min pre-
Clinical Study phototherapy, phase 2 is during 90 min of phototherapy and phase
Of 43 babies enrolled in the phototherapy group, 4 ba- 3 is 60 min post phototherapy. b Temperature measurements in a
bies were withdrawn due to needing a feed, and data from comparison group of babies not receiving phototherapy (n = 9).
another 10 babies were excluded due to movement arte- * p < 0.05.
fact, leaving data from 29 babies for analysis. Of 11 babies
enrolled in the control group, 3 were excluded due to
needing a feed. Baseline clinical data are shown in Ta- Statistically significant increases in pad, back and axillary
ble 1. The control babies tended to have a lower birth ges- temperatures were noted during 90 min of phototherapy.
tation and weight, but weight and corrected gestations The highest pad surface temperature recorded was 38.9 ° C.
were similar at the time of study. Axillary temperatures were greater than 37.5 ° C in 4 ba-
Table 2 shows mean (95% CI) temperatures for the pad bies, with a peak of 37.7 ° C. Pad and back temperature fell
surface, skin of the back and axilla in phototherapy and after turning the phototherapy lights off, but mean axillary
control (no-phototherapy) cohorts. The raw data for the temperature did not fall over this period and continued to
two groups are summarised using boxplots in Figure 4. rise in 8 babies. Two babies had low phase 1 axillary tem-
132.239.1.231 - 4/28/2017 7:53:40 AM
Univ. of California San Diego
Table 2. Temperatures (°C) in each study phase and changes in temperature between study phases for babies re-
ceiving phototherapy (n = 29) and for comparison babies not receiving phototherapy (n = 9)
Pad
PT 36.2 37.0 36.4 1.7* (1.4, 1.9) –1.4* (–1.6, –1.2)
No PT 36.3 36.3 36.3 0.2 (–0.3, 0.6) –0.1 (–0.5, 0.3)
Back
PT 36.6 37.5 36.9 0.6* (0.3, 0.8) –0.4* (–0.6, –0.2)
No PT 36.7 36.8 36.7 0.1 (–0.3, –0.5) 0.0 (–0.4, 0.4)
Axilla
PT 36.4 37.2 36.6 0.3* (0.1, 0.5) –0.1 (–0.3, 0.1)
Control 36.5 36.6 36.5 –0.1 (–0.5, 0.3) –0.1 (–0.5, 0.3)
peratures (Fig. 4); however, these were artefactual due to is due to blue light absorption. During clinical use, pad
intermittent loss of probe contact in the last 10 min of temperatures of up to 38.9 ° C were recorded. The extent
phase 1. Exclusion of these babies in the statistical model of pad heating is sufficient to cause net heat transfer to
had no effect on results and so these data were included in babies and reduce conductive heat loss. Under our study
the analysis. No changes in pad, back or axillary tempera- conditions, a statistically detectable increase in axillary
tures were noted across study periods in the control co- temperature occurred after 90 min of phototherapy. Axil-
hort. Pad, back and axillary temperatures were higher dur- lary temperature exceeded 37.5 ° C in several babies over
ing phototherapy when compared to the control group this short period indicating mild over-heating. This study
(pad: p = 0.002; back and axilla: p < 0.001). brings to clinical attention the fact that babies receiving
LED fibreoptic phototherapy at high irradiance are effec-
tively nursed on a warming blanket.
Discussion Heating of LED fibreoptic pads has not been recog-
nised in the literature. There have been no published clin-
Pad surface temperature increases during photothera- ical studies addressing temperature changes in the pad
py, and the increase correlates with light intensity. Ab- materials or effects of high intensity LED fibreoptic pho-
sorption of blue light by the pad plastic has also been totherapy on body temperature. Existing studies of fibre-
demonstrated. These results suggest that heating of pads optic phototherapy have used older systems, typically a
132.239.1.231 - 4/28/2017 7:53:40 AM
Univ. of California San Diego