COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Formation of bilirubin photoisomers in optimalized phototherapy of neonatal jaundice.
Scientific title
Early Isomerization of Bilirubin in Optimized phototherapy of neonatal jaundice
Secondary ID [1] 284849 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal jaundice 236940 0
Condition category
Condition code
Reproductive Health and Childbirth 292665 292665 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 292666 292666 0 0
Complications of newborn

Study type
Description of intervention(s) / exposure
Intensified phototherapy with single fluorescent unit (one Bilicompact light) vs Double fluorescent unit (double bilicompact. light) vs phototherapy with Photodiodes (Neoblue).
The neoBLUE unit emits blue LED light in the 450-470 nm with peak at 468 nm spectrum. This range corresponds to the bilirubin peak absorption wavelength of 458 nm.
BiliCompact contains ten 9W,12.7-cm length fluorescent bulbs (BAM/PL9/52, Ralutec 9W/71 G 23). These bulbs have broad Gaussian emission spectra roughly from 400 -525 nm with a peak at 450 nm and intense mercury emission lines at 405, 436, and 546 nm
Arm 1: Single phototherapy provided by one unit neoBLUE `Trademark`
Arm 2: Single phototherapy with single unit BiliCompact.`Trademark`. Arm 3: Double phototherapy was administered by two units BiliCompact`Trademark`.
We will take blood sample to analyse bilirubin photoisomer right befor starting phototherapy, after 30 min.60 min, 120 min Duration of phototherapy depends on the patient's response to phototherapy and how quickly falls serum total bilirbin. For this study, all children receive phototherapy at least 2-4 hours, because we are interested to see how quickly formed fotoisomerer after 15 min, 30min, 60 min, 120 min and 240 min.and 240 min. during phototherapy.
Intervention code [1] 236637 0
Treatment: Other
Comparator / control treatment
In our study we compare the effect of these types of phototherapy. We ciompared singel flourescent vs. single LED photodiodes vs double flourescent phototherapy.
By conventional phototherapy means the standard phototherapy which uses usually in the department, here is flourescent phototherapy. We would use intensive phototherapy to babies which needs phototherapy according to national Norwegean guidelines.
Phototherapy will provide by flourescent units
(1 or 2 lamps Bilicompact) and with single photodiodes (neoBLUE) unit at distance of 20 cm.The bed of patient will be covered inside with white linen and by hanging white linen around the unit .
Control group

Primary outcome [1] 238022 0
Formation of bilirubin isomers.
Stereoisomers of bilirubin formed during phototherapy.
We will measure these photoisomers by HPLC method. HPLC ( High-performance Liquid Chromaatography) for analyse of photoisomer.W will measure photoisomers who formed at 0 min, 15 min, 30 min., 60 min, 120 min & 240 min.
HPLC method: Bilirubin isomer were analyzed on a Dionex ultimate 3000 system , including a multiple wavelength detector ( Dionex, Sunnyvale, CA). The collumn used for HPLC was Kinetex core-shell 2,6 um C-18 ( 15 x0,46 cm).
Timepoint [1] 238022 0
From onset phototherapy until maximum 4 hours as function of time.
Secondary outcome [1] 242157 0
Duration of phototherapy.
Measuring the time of phototherapy.
Timepoint [1] 242157 0
0, 15, 30, 60, 120, 240 min.

Key inclusion criteria
Neonates with jaundice.

( Only neonate with jaundiice with BW > 1000 g)
Minimum age
1 Hours
Maximum age
2 Weeks
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Premature infants < 1000 g body weight

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Accepted by the local ethics committee. Informed consent from the parents. Closed envelopes with infomation of which treatment to provide.(random sorted)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Enrolled infants were randomized by drawing of sealed envelopes, to be treated with:
1) single fluorescent phototherapy (BiliCompact Infant or
2) double fluorescent phototherapy (BiliCompact), or
3) single unit photodiodes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6186 0
State/province [1] 6186 0

Funding & Sponsors
Funding source category [1] 289512 0
Self funded/Unfunded
Name [1] 289512 0
Address [1] 289512 0
Country [1] 289512 0
Primary sponsor type
Faculty of Medicine, University of Oslo
Faculty of Medicine
PO BOX 1078 Blindern, 0316 Oslo, Norway

Secondary sponsor category [1] 288199 0
Name [1] 288199 0
Address [1] 288199 0
Country [1] 288199 0

Ethics approval
Ethics application status
Ethics committee name [1] 271971 0
Regional Comitee for medical research ethics, South East Norway
Ethics committee address [1] 271971 0
Postboks 1130 Blindern
0318 Oslo
Ethics committee country [1] 271971 0
Date submitted for ethics approval [1] 271971 0
Approval date [1] 271971 0
Ethics approval number [1] 271971 0

Brief summary
Bilirubin photoisomers theoretically should be less able to cross the blood-brain barrier.Therfore it is of interest to study early bilirubin izomerization during phototherapy.
Trial website
Trial related presentations / publications
Mrehil k, Nakstad B, McDonaugh A.F, Hansen TWR. Early Isomerization of bilirubin in intensive phototherapy of neonatal jaundice. Ped Acad Sos 2842.403
SPAE-2009-0332 - Reversibility of acute intermediate phase bilirubin encephalopathy
Hansen TWR et al. Acta Ped (in press)
Public notes

Principal investigator
Name 29647 0
Dr Khalaf Mreihil
Address 29647 0
Department of Pediatrics and Adolescent medicine,
Akerhus University Hospital,
Country 29647 0
Phone 29647 0
Fax 29647 0
Email 29647 0
Contact person for public queries
Name 12894 0
Dr Khalaf Mreihil
Address 12894 0
Department of Pediatrics and Adolescent medicine,
Akerhus University Hospital,
Country 12894 0
Phone 12894 0
+47 91 33 76 07
Fax 12894 0
Email 12894 0;;
Contact person for scientific queries
Name 3822 0
Prof Hansen Thor Willy Ruud.
Address 3822 0
Women and Infants’ Division,
Oslo University Hospital-Rikshospitalet
Sognsvannsveien 20
Country 3822 0
Phone 3822 0
Fax 3822 0
Email 3822 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary