This study was planned as a single-center randomized controlled clinical trial to examine
the effect of the frequency of position changes on the time it takes for
hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal
Intensive Care Unit of Mersin City Training and Research Hospital.
Randomization and Masking: Randomization will be achieved by randomly and equally
distributing patients who meet the sample selection criteria to 2 groups (group 1 study
group and group 2 control group) through a computer program. Randomization will also be
stratified according to the feeding style of the babies, as breast-fed babies may affect
the duration of phototherapy. Stratified randomization will be performed according to
whether the babies are fed with breast milk or formula.
(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html).
Babies included in the study will be randomly divided into two groups by randomization
method. While the babies in the study group will be subjected to position changes
(supine, prone, lateral) every 2 hours, the same procedure will be applied to the control
group every 6 hours. All newborns included in the study were treated with the Unitest
(Blue angel) LED Phototherapy device, which is used as standard in the neonatal intensive
care unit, at a distance of 25-40 cm, at a wavelength of 425-475 nm, at 45 watts, at
50/60 Hz. Phototherapy will be applied unidirectionally. During phototherapy, only the
perineal area of the babies will be covered with a reduced diaper, and their eyes will be
covered with a three-layer, cotton, black eye patch that transmits 99.5% of ultraviolet
rays. During phototherapy sessions, the total serum bilirubin level of the patient is
checked; Phototherapy will be continued until it falls below the threshold value in the
Bhutani nomogram, which is evaluated according to postnatal days and risk factors. The
descriptive characteristics of the babies included in the study and their total bilirubin
and hematocrit values before the start of phototherapy will be recorded on the form
prepared by the researchers. After phototherapy begins, position changes will be made
every two hours for babies in the experimental group and every six hours for babies in
the control group until the total serum bilirubin value falls below the phototherapy
threshold value in the Bhutani nomogram.
Bilirubin levels will be measured and recorded by venous measurement at the sixth hour
and the 24th hour, and this process will be continued regularly until the bilirubin value
decreases to the normal range. This practice is performed routinely in the clinic and
will not be considered specific to the study.
In both groups, babies will start phototherapy in the prone position, and the patients
will continue to be fed 8 times a day, at 3-hour intervals, as the routine of the
neonatal intensive care unit. Babies will be fed by turning off phototherapy for a
maximum of 15 minutes, thus minimizing phototherapy interruption. Care will be taken not
to exceed this period for babies who are breastfed by their mothers.
Data Collection Tools
Baby Identification Information Form: The form includes descriptive characteristics of
the babies included in the study; It includes questions about their gender, mode of
birth, birth weight, gestational age, Apgar score, weight, bilirubin level and hematocrit
level.
Bhutani Nomogram: Each bilirubin value must be interpreted according to the "bilirubin
nomogram" prepared according to the baby's age in hours. The use of the nomogram
according to postnatal age allows monitoring the course of repeated bilirubin values and
predicting the baby who will later develop hyperbilirubinemia. This scale, known as the
"Bhutani nomogram" and has been widely used since 1999, will be used in our study.
Evaluation of Data The analysis of the data obtained from the research will be carried
out in the SPSS 22.0 statistical package program. The statistical significance level was
determined as 0.05. Kolmogrow-Smirnov will be used in the normality analysis of dependent
variables. Chi-square and comparison of means tests will be used to determine the
similarity of the groups. In comparing between and within groups averages, appropriate
parametric or non-parametric tests will be used, depending on whether the distribution is
normal. In addition, at the end of the research, whether the study has been conducted
with a sufficient sample size will be tested with post-hoc power analysis.