Continuous Versus Intermittent Phototherapy in Treatment of Neonatal

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06386731
Study type	Interventional
Source	Goztepe Prof Dr Suleyman Yalcin City Hospital
Contact
Status	Completed
Phase	N/A
Start date	July 5, 2022
Completion date	April 28, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04365998` - BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice	N/A
Completed	`NCT02222805` - Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment	N/A
Completed	`NCT01622699` - Implementation of a Transcutaneous Bilirubinometer	N/A
Completed	`NCT00692224` - Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial	Phase 1/Phase 2
Not yet recruiting	`NCT06080971` - Persistent Neonatal Jaundice on Neonates and Childern
Recruiting	`NCT06075290` - the Difference of Follow-up Methods of Neonatal Jaundice
Recruiting	`NCT05955144` - Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones	N/A
Recruiting	`NCT05127070` - Evaluating the NeoTree in Malawi and Zimbabwe
Completed	`NCT03306004` - Neonatal Jaundice: Knowledge, Attitudes and Practices of Mothers and Medical Trainees and Providers in and Around Ogbomosho	N/A
Completed	`NCT02774434` - Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age	N/A
Terminated	`NCT05365399` - Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population	N/A
Recruiting	`NCT03933423` - Home Based Phototherapy for Neonatal Jaundice	N/A
Recruiting	`NCT06399146` - Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana	N/A
Recruiting	`NCT03183986` - Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.	N/A
Withdrawn	`NCT00917007` - Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
Completed	`NCT06227624` - Role of Oral Zinc in Reducing Neonatal Indirect Hyperbilirubinemia	Phase 3
Completed	`NCT04433923` - Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants	N/A
Completed	`NCT04418180` - Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants	N/A
Not yet recruiting	`NCT05475223` - End Tidal Carbon Monoxide (ETCO): - A Tool to Aid Identification of Neonatal Hemolysis	N/A
Recruiting	`NCT03237715` - Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms