Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants
Status:
Not yet recruiting
Trial end date:
2028-12-01
Target enrollment:
Participant gender:
Summary
Background and study aims
When an infant is born premature, the blood vessels in the eyes have not developed fully on
the retina, and can start to grow incorrectly and result in blindness. To prevent this from
happening, premature infants are often screened, and treated with laser or injections into
the eye to prevent retinal detachment. A new treatment strategy with steroid eye drops have
been found to prevent serious blood vessel growth. The treatment is commonly used in older
children and adults to treat different inflammatory conditions, but how the drop is absorbed
in premature infants and if there is any risk of side-effects is poorly investigated. The aim
of this study is to document how the steroid drop is absorbed and excreted in premature
infants and to study if there is a risk of any side effects.
Who can participate?
Premature infants born before gestational age week 30, that undergo eye-screening at
Sahlgrenska University Hospital in Gothenburg and Skånes University Hospital in Malmö and
Lund, in the need for steroid eye-drop treatment against pathological vessels. It is not
possible to participate if the infant has received systemic steroid treatment 2 weeks prior
to the eye-drop treatment, or has an ongoing ocular infection.
What does the study involve?
The study involves blood and saliva samples according to a specific protocol designed to be
able to learn about the uptake and breakdown of the steroid in premature infants.
Measurements of blood pressure, growth and a few urine samples will also be collected during
the treatment period usually lasting for some weeks.
At 2.5 and 5 years of age, visual acuity, refractive errors and retinal thickness
measurements will be noted.
What are the possible benefits and risks of participating?
The infant will receive steroid eye-drops that have been noted to heavily reduce the number
of infants that develop retinal changes that require injections or laser treatment.
The blood samples have been reduced to an absolute minimum in volume and numbers, but will
entail some extra samplings from the infant.
The infant will be rigorously checked with regard to any possible side effects from the
steroid treatment. Possible but unlikely side effects from the low dose in eye drops are;
elevated blood pressure, retarded growth, lowered endogenous steroid production during the
eye-drop treatment, increase in blood glucose, and an increase in intra-ocular pressure.