The Effect of Position Change Frequency on Hyperbilirubinemia

March 21, 2024 updated by: Atiye Karakul, Tarsus University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Mersin, Turkey
        • Recruiting
        • Tarsus State Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Position group every 2 hours
Newborns in the study group will change position (supine, prone, lateral) every 2 hours.
Other: phototherapy treatment
The newborns in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours
No Intervention: Control group
Newborns in the control group will change position (supine, prone, lateral) every 6 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bhutani Nomogram
Time Frame: 1 day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
bilirubin level
Time Frame: 1 day
bilirubin level in blood
1 day
hematocrit levels
Time Frame: 1 day
hematocrit value in blood
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Investigators

  • Principal Investigator: Çağla Tarcan, Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

July 14, 2024

Study Completion (Estimated)

November 24, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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