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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot randomised clinical trial of 670nm red light for reducing retinopathy of prematurity
Scientific title
A pilot randomised clinical trial of 670nm red light for reducing retinopathy of prematurity
Secondary ID [1] 297547 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinopathy of prematurity 311770 0
Condition category
Condition code
Eye 310383 310383 0 0
Diseases / disorders of the eye
Reproductive Health and Childbirth 310466 310466 0 0
Complications of newborn

Study type
Description of intervention(s) / exposure
Preterm neonates will be randomized to receive either 15 minutes of 670 nm red light or no treatment daily from 24-48 hours after birth until 34 weeks corrected gestation. The treatment allocation will be delivered by nursing staff and adherence checked on bedside research proforma.
Intervention code [1] 313780 0
Comparator / control treatment
No red light treatment
Control group

Primary outcome [1] 319264 0
Retinopathy of prematurity as determined by an ophthalmologist using the international classification for staging of retinopathy of prematurity.
Timepoint [1] 319264 0
Most severe stage of retinopathy of prematurity diagnosed during the screening period from 32 weeks post conceptional age to retinal maturity.
Primary outcome [2] 319265 0
Survival to first discharge from hospital
Timepoint [2] 319265 0
Survival to first discharge from hospital
Secondary outcome [1] 367493 0
Sepsis during first hospital admission as confirmed by a positive blood culture.
Timepoint [1] 367493 0
Number of sepsis episodes during first hospital admission
Secondary outcome [2] 367794 0
Timepoint [2] 367794 0
To determine whether it is possible to randomize within 48 hours after birth

Key inclusion criteria
Less than 30 weeks gestation or less than 1150 grams at birth
Randomised within 48 hours after birth
Minimum age
0 Days
Maximum age
48 Hours
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Chromosomal or significant congenital anomalies

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was achieved by central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization - < 27 weeks gestation and >27 weeks gestation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Safety factors that will be observed are skin integrity and growth.
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Chi square test and the Mann-Whitney test for categorical variables. Cox regression to demonstrate independent influence of RED light on survival and ROP stage 3-4

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 302102 0
Other Collaborative groups
Name [1] 302102 0
Canberra Hospital Private Practice Fund
Address [1] 302102 0
Canberra Hospital, PO Box 11, Woden, 2606, ACT
Country [1] 302102 0
Primary sponsor type
Canberra Hospital
PO Box 11, Woden, 2606, ACT, Australia
Secondary sponsor category [1] 301932 0
Name [1] 301932 0
Address [1] 301932 0
Country [1] 301932 0

Ethics approval
Ethics application status
Ethics committee name [1] 302780 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 302780 0
Canberra Hospital, PO Box 11, Woden, 2606, ACT
Ethics committee country [1] 302780 0
Date submitted for ethics approval [1] 302780 0
Approval date [1] 302780 0
Ethics approval number [1] 302780 0

Brief summary
Retinopathy of Prematurity (ROP) is a vaso-proliferative disorder of the retina affecting extremely preterm or low birth weight infants. The most devastating consequence of ROP is retinal detachment and blindness, which in most developed countries is reduced by careful screening and early treatment with either laser ablation of vessels or intravitreal injection of anti-vascular endothelial growth factor (VEGF). However, ROP remains the leading cause of visual loss in children. Photobiomodulation using 670 nm red light might provide a novel treatment strategy to reduce the hyperoxic stage of ROP, by reducing the harmful effects of ROS and restoring normal vessel development. Photobiomodulation using 670nm red LED light in oxygen induced retinopathy animal models (which mimics facets of ROP including neonvascularisation and photoreceptor cell death) reduced the extent of oxygen induced retinal neovascularisation, decreased pulmonary haemorrhage and improved survival.The aims of this pilot randomised controlled trial were to: 1) determine feasibility of randomisation within 24-48 hours after birth; and 2) determine if treatment with 670nm red LED light at a distance of 25cm providing 9 J/cm2 in very premature neonates provided similar results to previously published animal studies in reducing ROP and improving survival.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 91378 0
Prof Alison Kent
Address 91378 0
Golisano Children's Hospital at University of Rochester, 601 Elmwood Avenue, Box 651, Rochester, 14642, NY
Country 91378 0
United States of America
Phone 91378 0
+1 585 2752645
Fax 91378 0
Email 91378 0
Contact person for public queries
Name 91379 0
Prof Alison Kent
Address 91379 0
Golisano Children's Hospital at University of Rochester, 601 Elmwood Avenue, Box 651, Rochester, 14642, NY
Country 91379 0
United States of America
Phone 91379 0
+1 585 2752645
Fax 91379 0
Email 91379 0
Contact person for scientific queries
Name 91380 0
Prof Alison Kent
Address 91380 0
Golisano Children's Hospital at University of Rochester, 601 Elmwood Avenue, Box 651, Rochester, 14642, NY
Country 91380 0
United States of America
Phone 91380 0
+1 585 2752645
Fax 91380 0
Email 91380 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Families not consented for sharing at the time of the study
What supporting documents are/will be available?
No other documents available
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
Eighty-six neonates were enrolled – 45 di not receive red light and 41 received red light. There was no difference in severity of Retinopathy Of Prematurity (ROP) in either of the two gestational age cohorts or requirement for laser treatment. Survival in the treatment group was 100% vs 89% in the untreated neonates. Randomisation to receive 670nm red light in the first 48 hours of life is safe and feasible. Further studies into the dosage and delivery methods of 670nm red light are required.