None listed
Conditions
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.
Interventions
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 f
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.
Sponsors
Canberra Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
24 Weeks to 30 Weeks
Healthy volunteers
No
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
Exclusion criteria
Significant chromosomal or congenital anomalies
Outcome results
None listed