The Effect of Position Change Frequency on Hyperbilirubinemia

Hyperbilirubinemia, Neonatal Clinical Trial

Official title: The Effect of Position Change Frequency on Hyperbilirubinemia in Term Infants Receiving Phototherapy

Status Recruiting

Clinical Trial Summary

In our study, the effect of the frequency of position changes on hyperbilirubinemia in babies hospitalized in the Neonatal Intensive Care Unit and receiving phototherapy treatment will be investigated.

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.

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Newborn; Vitality

• NCT number: NCT06324799
• Study type: Interventional
• Source: Tarsus University
• Contact: Atiye Karakul, Assoc.prof
• Phone: +903246000033
• Email: atiyekarakul@tarsus.edu.tr
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Completion date: November 24, 2024