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Trial registered on ANZCTR


Registration number
ACTRN12612001257853
Ethics application status
Not yet submitted
Date submitted
27/11/2012
Date registered
29/11/2012
Date last updated
29/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Red light (670nm) treatment to prevent retinopathy of prematurity (ROP)
Scientific title
Red light (670nm) treatment to prevent retinopathy of prematurity (ROP)
Secondary ID [1] 281592 0
None
Universal Trial Number (UTN)
Trial acronym
RED ROP study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinopathy of prematurity 287874 0
Chronic Lung Disease 287879 0
Condition category
Condition code
Eye 288239 288239 0 0
Diseases / disorders of the eye
Respiratory 288248 288248 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Premature neonates less than 30 weeks gestation or less than 1150 grams birthweight will be exposed to 670nm red light treatment daily for 15 minutes (9 Joules/cm2) from the first 24-48 hours of life until 34 weeks corrected age. The 670nm red light used will be the WARP 75 (Registered trademark light) (Food and Drug Administration (FDA) cleared for market medical devices (US Patent # 6,796,994 issued Sept. 2004)) which is placed on top of the neonates isolette 25cm above the baby in a similar fashion to that of phototherapy for hyperbilirubinaemia. Routine ophthalmological follow-up as inpatients will occur along with neurodevelopmental follow-up and ophthalomological follow-up at 2-3 years of age.
Intervention code [1] 286120 0
Prevention
Intervention code [2] 286135 0
Treatment: Other
Intervention code [3] 286136 0
Treatment: Devices
Comparator / control treatment
This is a small phase 2 study looking at feasibility and efficacy. All neonates enrolled in the study will receive the treatment - there will be no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288430 0
670nm red light will reduce the incidence of all stages of retinopathy of prematurity. Eye examinations will be performed by Ophthalmologists and the internationally accepted staging of ROP will be utilised according to standard examination guidelines commencing at 32 weeks corrected age until the retina is vascularised at term corrected age. The worst stage of ROP in either eye at term corrected age will be collected.
Timepoint [1] 288430 0
The above final outcome will be assessed at term corrected age (this is a standard term for neonates born extremely premature and is designated as 40 weeks).
Secondary outcome [1] 300142 0
670nm red ight will reduce the incidence of retinopathy of prematurity requiring laser surgery. Eye examinations will be performed by Ophthalmologists and the internationally accepted staging of ROP will be utilised according to standard examination guidelines commencing at 32 weeks corrected age until the retina is vascularised at term corrected age. If laser surgery is required to treat stage 3 ROP this data will be collected.
Timepoint [1] 300142 0
The above final outcome will be assessed at term corrected age (this is a standard term for neonates born extremely premature and is designated as 40 weeks).
Secondary outcome [2] 300143 0
670nm red light will reduce the incidence of chronic lung disease of prematurity. This outcome is determined by the universally standard definition of a neonate requiring oxygen or any respiratory support at 36 weeks corrected age.
Timepoint [2] 300143 0
The above final outcome will be assessed at 36 weeks corrected age the universally accepted definition for chronic lung disease of prematurity

Eligibility
Key inclusion criteria
Premature neonates less than 30 weeks gestation or less than 1150 grams birthweight
Informed consent obtained in the first 24-48 hours of life
Minimum age
24 Weeks
Maximum age
30 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant chromosomal or congenital anomalies

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents of premature neonates will be approached within the first 24-48 hours to consider participation in the study. All enrolled neonates will receive the treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)

Funding & Sponsors
Funding source category [1] 286400 0
Hospital
Name [1] 286400 0
Canberra Hospital Private Practice Fund
Address [1] 286400 0
Canberra Hospital
PO Box 11
Woden, 2606
ACT
Country [1] 286400 0
Australia
Primary sponsor type
Hospital
Name
Canberra Hospital
Address
Canberra Hospital
PO Box 11
Woden, 2606
ACT
Country
Australia
Secondary sponsor category [1] 285185 0
University
Name [1] 285185 0
John Curtin School of Medical Research
Address [1] 285185 0
Australian National University
Canberra, 2601
ACT
Country [1] 285185 0
Australia
Other collaborator category [1] 277202 0
University
Name [1] 277202 0
John Curtin School of Medical Research
Address [1] 277202 0
Australian National University
Canberra, 2601
ACT
Country [1] 277202 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288463 0
ACT HREC
Ethics committee address [1] 288463 0
ACT Health Directorate Research Office
Building 10 Level 6
Canberra Hospital
PO Box 11
Woden, 2606
ACT
Ethics committee country [1] 288463 0
Australia
Date submitted for ethics approval [1] 288463 0
12/11/2012
Approval date [1] 288463 0
Ethics approval number [1] 288463 0
ETH 9.12.211

Summary
Brief summary
Retinopathy of prematurity is a common complication of very premature delivery (less than 30 weeks gestation) and without appropriate screening and treatment can lead to retinal detachment and blindness. It is the leading cause of blindness in children. While in the uterus the fetus and the retina is developing in an environment where the partial pressure of oxygen is only 25-35 mmHg. Following premature delivery the retina is then exposed to partial pressures of oxygen of 60 mmHg and above. ROP has been shown to occur as a result of this hyperoxic exposure, and despite tight control on oxygen saturations which has led to a significant reduction in the disease, ROP still occurs in some part due to the fact that the retina is not meant to develop in this hyperoxic environment. Exacerbating this situation is that many of the neonates at most risk of ROP have significant lung disease of prematurity and as a consequence have recurrent episodes of hyper and hypoxia which occur despite attempts at tight control of oxygen delivery. 670nm red light is thought to act on the cytochrome c oxidative pathway (within cells of the body), which reduces the presence and production of oxygen free radicals. 670nm red light has been shown to reduce ROP in a mice and rat animal model. It has been used safely in the treatment of soft tissue injuries and mouth ulcers following radiation treatment and studies are ongoing with its use in diabetic retinopathy and age-related macular degeneration. This study aims to look at whether 670nm red light reduces the incidence of any stage of ROP and the incidence of ROP requiring laser surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34987 0
Address 34987 0
Country 34987 0
Phone 34987 0
Fax 34987 0
Email 34987 0
Contact person for public queries
Name 18234 0
A/Prof Alison Kent
Address 18234 0
Dept of Neonatology
Canberra Hospital
Centenary Hospital for Women and Children
PO Box 11
Woden, 2606
ACT
Country 18234 0
Australia
Phone 18234 0
+61 2 6174 7565
Fax 18234 0
+61 2 6174 5747
Email 18234 0
alison.kent@act.gov.au
Contact person for scientific queries
Name 9162 0
A/Prof Alison Kent
Address 9162 0
Dept of Neonatology
Canberra Hospital
Centenary Hospital for Women and Children
PO Box 11
Woden, 2606
ACT
Country 9162 0
Australia
Phone 9162 0
+61 2 6174 7565
Fax 9162 0
+61 2 6174 5747
Email 9162 0
alison.kent@act.gov.au

No information has been provided regarding IPD availability
Summary results
No Results