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Completed

NCT Number: NCT06386731

Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice

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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Key information

Age range

1 day–15 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Göztepe Prof. Dr. Suleyman Yalcin City Hopital

Kadıköy, Istanbul, 34730, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent Phototherapy

Other

2-hour phototherapy application in the intervention group

Other names: Phototherapy duration

Primary outcomes

  1. 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

Secondary outcomes

  1. Comparison of side effect frequency of CPT and IPT

    Time frame: 10 months

    Comparison of frequency of skin rash, increase in body temperature, diarrhea

Sponsors and collaborators

Lead sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 26, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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