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Trial registered on ANZCTR


Registration number
ACTRN12619000371190
Ethics application status
Approved
Date submitted
27/02/2019
Date registered
11/03/2019
Date last updated
21/02/2020
Date data sharing statement initially provided
11/03/2019
Date results information initially provided
11/03/2019
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
None
Universal Trial Number (UTN)
U1111-1229-3184
Trial acronym
RED ROP RCT
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

Intervention/exposure
Study type
Interventional
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
Prevention
Comparator / control treatment
No red light treatment
Control group
Active

Outcomes
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
Feasibility
Timepoint [2] 367794 0
To determine whether it is possible to randomize within 48 hours after birth

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chromosomal or significant congenital anomalies

Study design
Purpose of the study
Prevention
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
Parallel
Other design features
Safety factors that will be observed are skin integrity and growth.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
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
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 in Australia
Recruitment state(s)
ACT

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
Australia
Primary sponsor type
Hospital
Name
Canberra Hospital
Address
PO Box 11, Woden, 2606, ACT, Australia
Country
Australia
Secondary sponsor category [1] 301932 0
None
Name [1] 301932 0
None
Address [1] 301932 0
None
Country [1] 301932 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 302780 0
04/08/2014
Approval date [1] 302780 0
15/02/2015
Ethics approval number [1] 302780 0
ETH.7.14.160

Summary
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

Contacts
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
alison_kent@urmc.rochester.edu
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
alison_kent@urmc.rochester.edu
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
alison_kent@urmc.rochester.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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?
No
Other publications
Have study results been made publicly available in another format?
No
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.