Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice

April 23, 2024 updated by: Sibel Sevuk Ozumut, Goztepe Prof Dr Suleyman Yalcın City Hospital

Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice: A Randomized Controlled Trial

One of the most common diseases in the neonatal period is indirect hyperbilirubinemia (IHB). After phototherapy was discovered accidentally in 1958, it has been used as the most effective treatment method for IHD for more than 60 years. Sources that provide phototherapy are developing rapidly technologically. However, there is no clearly defined usage table in the literature for applying phototherapy with faster effects and fewer side effects. In recent years, the use of intermittent phototherapy has been recommended with similar effectiveness. Phototherapy has significant side effects such as dehydration, diarrhea, chromosome breaks, retinal damage, skin rashes, hypocalcemia, thrombocytopenia. As phototherapy exposure decreases, its side effects decrease.In our study; We plan to find the most ideal method in the treatment of IHB by comparing intermittent PT with continuous phototherapy in terms of effectiveness. We aim to achieve the best bilirubin reduction and minimal side effects with less exposure to phototherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

n the intermittent phototherapy group, phototherapy will be applied for 1 hour and phototherapy will be turned off for 2 hours, allowing time for the skin to be cleaned. The 3-hour cycle is completed twice and the 6-hour session is completed, and at the end, the total bilirubin will be measured and the hourly bilirubin decrease rate will be calculated.

In the continuous phototherapy group, total bilirubin will be measured at the end of 6 hours of uninterrupted phototherapy and the hourly bilirubin decrease rate will be calculated.

It was planned to compare the effectiveness of the two groups in terms of the bilirubin level reduced as a result of 6-hour sessions, hourly reduction rate, rebound bilirubin level, total phototherapy time received, hospitalization time, and additional treatments required.

It was planned to compare both groups in terms of the frequency of side effects such as the number of defecations, body temperature changes, and skin rash during the phototherapy session.

Study Type

Interventional

Enrollment (Actual)

225

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 Locations

  • Turkey
    • İstanbul
      • Kadıköy, İstanbul, Turkey, 34730
        • Göztepe Prof. Dr. Suleyman Yalcin City Hopital

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:

The inclusion criteria was being a late preterm or term neonate who had IHB in the first 15 days of life-

Exclusion Criteria:

  • Those who had sTB values at the blood exchange limit according to the nomogram, any associated congenital anomalies including chromosomal anomalies or were less than 34th gestational week were excluded.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intermittent phototherapy group
In the intermittent phototherapy group, phototherapy will be applied for 1 hour, phototherapy will be turned off for 2 hours, and time will be left for cleansing from the skin. The 3-hour cycle is completed twice and the 6-hour session is completed, and at the end, the total bilirubin will be measured and the hourly bilirubin decrease rate will be calculated.
Other: Intermittent Phototherapy
2-hour phototherapy application in the intervention group
Other Names:
  • Phototherapy duration
Other: continuous phototherapy group
In the continuous phototherapy group, total bilirubin will be measured at the end of 6 hours of uninterrupted phototherapy and the hourly bilirubin decrease rate will be calculated.
Other: Intermittent Phototherapy
2-hour phototherapy application in the intervention group
Other Names:
  • Phototherapy duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the effectiveness of CPT and IPT
Time Frame: 10 months
The primary outcome was to compare the therapeutic efficacy of IPT and CPT
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of side effect frequency of CPT and IPT
Time Frame: 10 months
Comparison of frequency of skin rash, increase in body temperature, diarrhea
10 months

Collaborators and Investigators

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

Sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital

Investigators

  • Study Chair: Fahri Ovalı, Prof, Istanbul Medeniyet 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.

Helpful Links

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)

July 5, 2022

Primary Completion (Actual)

November 25, 2022

Study Completion (Actual)

April 28, 2023

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNEO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

Medical doctors and medical students who will conduct research on the subject can access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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