The Effect of Position Change Frequency on Hyperbilirubinemia

NCT06324799 | Completed

• 1 other identifier: 2023/51
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Newborn; Vitality; Hyperbilirubinemia, Neonatal

Keywords

Hyperbilirubinemia; newborn; Phototherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• bilirubin level

  1 day

• hematocrit levels

  1 day

Study Arms (2)

Position group every 2 hours

EXPERIMENTAL

Newborns in the study group will change position (supine, prone, lateral) every 2 hours.

Other: phototherapy treatment

Control group

NO INTERVENTION

Newborns in the control group will change position (supine, prone, lateral) every 6 hours.

Interventions

phototherapy treatment OTHER

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

Position group every 2 hours

Eligibility Criteria

• Age: 1 Day - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus State Hospital

Mersin, Turkey (Türkiye)

Location

Related Publications (10)

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

  RESULT

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

  RESULT

• Ovalı F., Dağoğlu T. Neonatoloji. İndirekt Hiperbilirubinemi. 3. Baskı İstanbul: Nobel Tıp Kitabevleri Tic. Ltd. Şti.; 2018. p. 959-84.

  RESULT

• 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):795-9. doi: 10.1038/jp.2013.54. Epub 2013 Jun 6.

  PMID: 23743672 RESULT

• 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.

  PMID: 35235686 RESULT

• 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.

  PMID: 11948386 RESULT

• Akkuzu, A. (2021). Hiperbilirubinemi tanısı ile yenidoğan yoğun bakım ünitesinde yatan bebeklerin beslenme şekilleri ile hastanede kalış süreleri arasındaki ilişki (Master's thesis, İstanbul Medipol Üniversitesi Sağlık Bilimleri Enstitüsü).

  RESULT

• 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.

  PMID: 20528799 RESULT

• 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.

  PMID: 25319831 RESULT

• 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.

  PMID: 12607480 RESULT

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Çağla Tarcan

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 22, 2024
• Study Start: March 14, 2024
• Primary Completion: September 14, 2024
• Study Completion: March 24, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)