RecruitingACTRN12617000479303

Comparison of Thresholds for Phototherapy in Newborns <32 weeks gestational age

Does a higher threshold for phototherapy worsen the rate of rise in bilirubin in the first 72 hours of life for neonates <32 weeks gestation age?

Sponsor

Srinivas Bolisetty

Enrollment

60 participants

Start Date

Mar 17, 2017

Study Type

Observational

Conditions

Neonatal Jaundice

Summary

The purpose of the study is to determine whether higher threshold for commencing phototherapy will worsen the rate of rise in bilirubin in the first 72 hours of life in newborns born <32 weeks gestational age. We hypothesise that the higher threshold for phototherapy will result in similar trends in bilirubin levels, duration of phototherapy and number of infants reaching bilirubin levels <25umol/L below exchange threshold in both groups.

Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 72 Hourss

Plain Language Summary

Simplified for easier understanding

This study is comparing two different levels of bilirubin (jaundice) at which doctors start phototherapy (light treatment) in premature babies born before 32 weeks. Researchers want to know if using a higher threshold before starting phototherapy is safe and does not lead to dangerously high bilirubin levels. You may be eligible if: - Your baby was born at less than 32 weeks gestational age - Your baby is less than 72 hours old and requires phototherapy You may NOT be eligible if: - Your baby has known congenital abnormalities - Your baby has blood group incompatibility, G6PD deficiency, or significant bruising that puts them at higher risk of jaundice - Your baby has conjugated (direct) hyperbilirubinemia Talk to your doctor about whether this trial might be right for you.

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

This is a prospective observational study with historical controls. It will be focusing on neonatal outcomes (e.g. serum bilirubin, duration of phototherapy, etc) after phototherapy has been commenced according to the guidelines introduced. In the new guideline, phototherapy threshold is as follows: initiated at 60umol/L at 0 hours. Thresholds increases in a straight line until it reaches the value at the 72 hour plateau from the UK NICE guidelines. The new guidelines were introduced as part of standard care delivered at the site. This project is a quality improvement trial. The prospective group will be observed from 17/03/17 to 17/09/17. The follow-up period for each participant will be until discharge. As the exposure is the new guidelines that have been established within the NICU, it will be delivered by the NICU staff. The decision to start phototherapy, duration and type is determined, as per standard practice, by the attending physician and their team.

Locations(1)

Royal Hospital for Women - Randwick

NSW, Australia

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