Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants - Trial NCT05387941

Timeline & Enrollment

Primary Outcome

Pharmacokinetics: half-life of plasma concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.,Pharmacokinetics: maximum plasma concentration of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.,Pharmacokinetics: saliva koncentrations of dexamethasone during treatment with dexamethasone eye drops.,Pharmacokinetics: saliva koncentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.,Pharmacokinetics: time to reach maximum plasma concentration of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.,Pharmacokinetics: time to reach maximum saliva concentrations of dexamethasone during treatment with dexamethasone eye drops measured with mass spectrometry.,Pharmacokinetics: area under the concentration-time curve for plasma dexamethasone from time point 0 to time t of the last measured concentration above the limit of quantification time.,Pharmacokinetics: area under the concentration-time curve for saliva dexamethasone from time point 0 to time t of the last measured concentration above the limit of quantification time.,Pharmacokinetics: area under the concentration-time curve for plasma dexamethasone from time point 0 to infinity;,Pharmacokinetics: area under the concentration-time curve for saliva dexamethasone from time point 0 to infinity;,Pharmacokinetics: apparent total body clearance,Pharmacokinetics: apparent volume of distribution,Safety: serum concentrations of endogenous corticosteroids before, during and after treatment with dexamethasone eye drops measured with mass spectrometry.,Safety: saliva concentrations of endogenous corticosteroids before, during and after treatment with dexamethasone eye drops.

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.

ICD-10 Classifications