Formation of bilirubin photoisomers in optimalized phototherapy of neonatal jaundice.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000716662
• Date of registration: 07/07/2014
• Prospective Registration: No
• Primary sponsor: Faculty of Medicine, University of Oslo
• Public title: Formation of bilirubin photoisomers in optimalized phototherapy of neonatal jaundice.
• Scientific title: Early Isomerization of Bilirubin in Optimized phototherapy of neonatal jaundice
• Date of first enrolment: 28/05/2009
• Target sample size: 42
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000716662.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Norway

Contacts

• Name: Prof Hansen Thor Willy Ruud.

• Name: Dr Khalaf Mreihil

Key inclusion & exclusion criteria

Inclusion criteria: Neonates with jaundice.

( Only neonate with jaundiice with BW > 1000 g)

Exclusion criteria: Premature infants < 1000 g body weight

Age minimum: 1 Hours
Age maximum: 2 Weeks
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neonatal jaundice;
Neonatal jaundice

Reproductive Health and Childbirth - Childbirth and postnatal care

Reproductive Health and Childbirth - Complications of newborn

Intervention(s)

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.

Primary Outcome(s)

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).[From onset phototherapy until maximum 4 hours as function of time.]

Secondary Outcome(s)

Duration of phototherapy.
Measuring the time of phototherapy.[0, 15, 30, 60, 120, 240 min.]

Secondary ID(s)

nil

Source(s) of Monetary Support

Unfunded

Ethics review

Status: Approved
Approval date:
Contact:

Regional Comitee for medical research ethics, South East Norway