Skin exposure during conventional phototherapy in preterm infants: A Randomised Controlled Trial
Phase 3
Completed
- Conditions
- Reproductive Health and Childbirth - Complications of newbornPreterm infants with physiological jaundice
- Registration Number
- ACTRN12606000474550
- Lead Sponsor
- The University of Queensland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Preterm infants in the special care nursery at the Royal Brisbane Women’s Hospital with birthweight >1500grams, gestation >36 weeks and non-haemolytic hyperbilirubinemia (direct Coombs test negative, no blood group incompatibility) determined by total serum bilirubin levels to be within phototherapy range using Cockington criteria were considered for enrollment.
Exclusion Criteria
Infants with congenital abnormality or known coexisting pathologies or need for respiratory support.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome was mean total serum bilirubin percentage change to the end of 24-hour treatment after trial entry. The mean total serum bilirubin percentage change was calculated for the 24-hour change from the baseline level at trial entry.[Total serum bilirubin levels were measured after the first 24-hours of treatment by direct spectrophotometry (Reichert Unistat-Bilirubinometer) by laboratory technicians blinded to the study group.]
- Secondary Outcome Measures
Name Time Method Incidence of rebound jaundice confirmed by total serum bilirubin and requiring an additional course of phototherapy treatment and number of infants continuing to receive phototherapy treatment based on total serum bilirubin levels.[Measured at the end of each 24-hour period.];Parental stress and mother-infant interaction was assessed using the Parenting Stress Index-Short Form.[Within 24-hours of ceasing phototherapy. ];The mean total serum bilirubin percentage change in infants who remained within phototherapy range.[After the first 24-hour period was also examined at 48 hours completed phototherapy treatment.];Any episode of patent ductus arteriosus, skin rashes or dehydration (infant requiring intra-venous fluid resuscitation) was recorded.[]