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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324799
• Other study ID #: 2023/51
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: November 24, 2024

Study information

• Verified date: March 2024
• Source: Tarsus University
• Contact: Atiye Karakul, Assoc.prof
• Phone: +903246000033
• Email: atiyekarakul[@]tarsus.edu.tr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 24, 2024
• Est. primary completion date: July 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 15 Days

Eligibility

Inclusion Criteria:

• Born after 37 weeks of gestation, receiving treatment at Mersin City Training and Research Hospital Neonatal Intensive Care Service,
• There is an indication for phototherapy treatment in the phototherapy nomogram, where the total serum bilirubin value is evaluated according to the patient's postnatal day and risk factors,
• Postnatal 1-15. on the day,
• Patients whose families approve the informed consent form.

Exclusion Criteria:

• Older than the 15th postnatal day,
• There is an indication for exchange transfusion in the blood exchange curve, where the total serum bilirubin value is evaluated according to the patient's day and risk factors,
• Having a major anomaly or disease detected antenatally,
• Patients with comorbid diseases such as perinatal asphyxia, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, congenital heart disease and similar diseases will not be included in the study.

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Newborn; Vitality

Intervention

Other:
• phototherapy treatment
The newborns in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours

Locations

Country	Name	City	State
Turkey	Tarsus State Hospital	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Tarsus University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Akkuzu, A. (2021). Hiperbilirubinemi tanisi ile yenidogan yogun bakim ünitesinde yatan bebeklerin beslenme sekilleri ile hastanede kalis süreleri arasindaki iliski (Master's thesis, Istanbul Medipol Üniversitesi Saglik Bilimleri Enstitüsü).

American Academy of Pediatrics, Clinical Practice Guideline, Subcommittee on Hyperbilirubinemia. Management

Bhethanabhotla S, Thukral A, Sankar MJ, Agarwal R, Paul VK, Deorari AK. Effect of position of infant during phototherapy in management of hyperbilirubinemia in late preterm and term neonates: a randomized controlled trial. J Perinatol. 2013 Oct;33(10):795 — View Citation

Chen CM, Liu SH, Lai CC, Hwang CC, Hsu HH. Changing position does not improve the efficacy of conventional phototherapy. Acta Paediatr Taiwan. 2002 Sep-Oct;43(5):255-8. — View Citation

Donneborg ML, Knudsen KB, Ebbesen F. Effect of infants' position on serum bilirubin level during conventional phototherapy. Acta Paediatr. 2010 Aug;99(8):1131-4. doi: 10.1111/j.1651-2227.2010.01885.x. Epub 2010 Jun 2. — View Citation

Karen Marcdante & Robert M. Kliegman & Abigail M. Schuh. 2023 Nelson Essentials of Pediatrics 9th edition. 2022. p. 953-60.

Lee Wan Fei S, Abdullah KL. Effect of turning vs. supine position under phototherapy on neonates with hyperbilirubinemia: a systematic review. J Clin Nurs. 2015 Mar;24(5-6):672-82. doi: 10.1111/jocn.12712. Epub 2014 Oct 16. — View Citation

Ovali F., Dagoglu T. Neonatoloji. Indirekt Hiperbilirubinemi. 3. Baski Istanbul: Nobel Tip Kitabevleri Tic. Ltd. Sti.; 2018. p. 959-84.

Shinwell ES, Sciaky Y, Karplus M. Effect of position changing on bilirubin levels during phototherapy. J Perinatol. 2002 Apr-May;22(3):226-9. doi: 10.1038/sj.jp.7210678. — View Citation

Thukral A, Deorari A, Chawla D. Periodic change of body position under phototherapy in term and preterm neonates with hyperbilirubinaemia. Cochrane Database Syst Rev. 2022 Mar 2;3(3):CD011997. doi: 10.1002/14651858.CD011997.pub2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	bilirubin level	bilirubin level in blood	1 day
Secondary	hematocrit levels	hematocrit value in blood	1 day