Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2023-04-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neonatal Jaundice Phototherapy Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a single-center, with block randomisation \[1:1\], open-label, parallel group study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intermittent Phototherapy

Intervention Type OTHER

2-hour phototherapy application in the intervention group

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.

Group Type OTHER

Intermittent Phototherapy

Intervention Type OTHER

2-hour phototherapy application in the intervention group

Interventions

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Intermittent Phototherapy

2-hour phototherapy application in the intervention group

Intervention Type OTHER

Other Intervention Names

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Phototherapy duration

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

15 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No