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

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

Inclusion Criteria2

  • Babies <72 hrs old who undergo phototherapy
  • Babies born at <32 weeks gestational age

Exclusion Criteria3

  • Known congenital anomalies
  • Known risk factors for hyperbilirubinemia including blood group incompatibility, G6PD deficiency, multiple bruising
  • Conjugated hyperbilirubinemia

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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

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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