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Trial registered on ANZCTR


Registration number
ACTRN12614000716662
Ethics application status
Approved
Date submitted
26/05/2009
Date registered
7/07/2014
Date last updated
7/07/2014
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
nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

Eligibility
Key inclusion criteria
Neonates with jaundice.

( Only neonate with jaundiice with BW > 1000 g)
Minimum age
1 Hours
Maximum age
2 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Premature infants < 1000 g body weight

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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

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

Country
Norway
Secondary sponsor category [1] 288199 0
None
Name [1] 288199 0
None
Address [1] 288199 0
Country [1] 288199 0

Ethics approval
Ethics application status
Approved
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
Norway
Date submitted for ethics approval [1] 271971 0
03/01/2009
Approval date [1] 271971 0
14/01/2009
Ethics approval number [1] 271971 0
S-06385a

Summary
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

Contacts
Principal investigator
Name 29647 0
Dr Khalaf Mreihil
Address 29647 0
Department of Pediatrics and Adolescent medicine,
Akerhus University Hospital,
Sykehusveien
1472-Lorenskog
Norway
Country 29647 0
Norway
Phone 29647 0
+4791337607
Fax 29647 0
Email 29647 0
khalaf.mreihil@medisin.uio.no
Contact person for public queries
Name 12894 0
Dr Khalaf Mreihil
Address 12894 0
Department of Pediatrics and Adolescent medicine,
Akerhus University Hospital,
Sykehusveien
1472-Lorenskog
Norway
Country 12894 0
Norway
Phone 12894 0
+47 91 33 76 07
Fax 12894 0
Email 12894 0
khalaf.mreihil@medisin.uio.no;khalaf.mreihil@ahus.no;khalafm@broadpark.no
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
0027-Oslo
Country 3822 0
Norway
Phone 3822 0
+4723074573
Fax 3822 0
Email 3822 0
t.w.r.hansen@medisin.uio.no

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