RecruitingACTRN12624000860561

Intermittent Phototherapy vs Continuous Phototherapy in Treating Neonatal Jaundice - A Randomized Controlled Trial

Changes in Bilirubin with Intermittent Phototherapy vs Continuous Phototherapy for Treating Neonatal Jaundice - A Randomized Controlled Trial


Sponsor

Universiti Sains Malaysia

Enrollment

74 participants

Start Date

Aug 1, 2024

Study Type

Interventional

Conditions

Summary

This is a randomized controlled trial to compare the effectiveness of intermittent phototherapy vs continous phototherapy in treating neonatal jaundice. Our hypothesis is intermittent phototherapy is as effective as continuous phototherapy. If our hypothesis is proven in this study, thus we can apply intermittent phototherapy in our practice. By using the data, we can practice daycare phototherapy to minimize ward congestion and improve resources management.


Eligibility

Sex: Both males and femalesMin Age: 24 HourssMax Age: 14 Dayss

Plain Language Summary

Simplified for easier understanding

Newborn jaundice — where a baby's skin and eyes turn yellow due to high levels of bilirubin in the blood — is extremely common. When bilirubin levels are high enough to require treatment, phototherapy (placing the baby under special blue lights) is the standard approach. Currently, most phototherapy is given continuously, meaning the lights stay on all the time. This study is testing whether giving phototherapy intermittently (cycling the lights on and off at regular intervals) is just as effective as continuous phototherapy. If the results are similar, intermittent phototherapy could allow babies to be treated on a day-stay basis rather than staying in hospital overnight, which would be more comfortable for families and help manage hospital resources. Your baby may be eligible if they are between 24 hours and 2 weeks old, were born at 38 weeks or later, weigh more than 2.5 kg, and have bilirubin levels that require phototherapy but are not severe enough to require intensive treatment. Babies with conditions like ABO incompatibility, G6PD deficiency, or clinical sepsis would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intermittent Phototherapy. Babies who fulfil inclusion criteria will be selected into the study. Baseline serum bilirubin will be taken. They will undergo phototherapy for 10 hours and phototherapy wi

Intermittent Phototherapy. Babies who fulfil inclusion criteria will be selected into the study. Baseline serum bilirubin will be taken. They will undergo phototherapy for 10 hours and phototherapy will stop. After 6 hours without phototherapy, venous blood gas will be taken to see the bilirubin level as to prevent rebound jaundice. If the level requires phototherapy, we will restart the phototherapy and withdraw them from study to proceed with standard treatment. If they do not require phototherapy, another serum bilirubin will be taken at 24 hours of study. If they require another phototherapy, it is considered treatment failure. We will restart the phototherapy and proceed with standard treatment. The level that used to decide babies requiring phototherapy will be based on their age and risk following Malaysia Paediatric Protocol page 139. The phototherapy machine used is the same for both groups which is Babyblue LED Phototherapy Unit. It consists of 8 LED lights at the top chamber each delivering 25 - 35 µW/cm²/nm. To ensure adherence to the intervention, we will place baby in a cot and place them under phototherapy. The nursing time is same for all babies, this is to minimize interruption of treatment. Medical Officer and nurses will participate in this intervention including starting phototherapy, blood taking and nursing care of the patient,


Locations(1)

Malaysia

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