Using Dexamethasone Eye Drops to Treat Preterm Infants
Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants With Retinopathy of Prematurity- a Feasibility Study
This study is testing if dexamethasone eye drops can safely help prevent vision problems in premature infants born before 30 weeks.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | N/A to 30 Weeks |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 2 sites (Lund, Skåne and 1 other locations) |
| Trial ID | NCT05387941 on ClinicalTrials.gov |
What this trial studies
This study investigates how dexamethasone eye drops are absorbed and excreted in premature infants to prevent retinopathy of prematurity, a condition that can lead to blindness. The research focuses on infants born before 30 weeks of gestation who are screened for this condition at specific hospitals in Sweden. By documenting the pharmacokinetics and assessing potential side effects, the study aims to provide insights into the safety and efficacy of this treatment in a vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are premature infants born before 30 weeks of gestation who are undergoing eye screening for retinopathy of prematurity.
Not a fit: Patients with ocular infections or those who have received systemic steroid treatment within two weeks prior to the study may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of blindness in premature infants.
How similar studies have performed: While the use of dexamethasone is established in older populations, this specific application in premature infants is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants screened for retinopathy of prematurity (ROP) at Sahlgrenska University Hospital in Gothenburg, at Skåne University Hospital in Malmö and Lund and at Helsingborg Hospital. * zone I stage 1 or 2 ROP without plus disease, posterior zone II stage 2 ROP without plus disease, or zone II stage 3 ROP without plus disease. ROP needs to be documented by digital widefield photography and classification confirmed by two ophthalmologist. Exclusion Criteria: * ocular infection * systemic steroid treatment within two weeks before the start of drop treatment
Where this trial is running
Lund, Skåne and 1 other locations
- Skåne University Hospital — Lund, Skåne, Sweden (Recruiting)
- Sahlgrenska University Hospital — Göteborg, Västra Götaland, Sweden (Recruiting)
Study contacts
- Principal investigator: Hanna Maria Öhnell, PhD — Ophthalmology, dep. of clinical sciences Lund, Lund University, Skåne University Hospital, Sweden
- Study coordinator: Hanna Maria Öhnell, PhD
- Email: hanna_maria.ohnell@med.lu.se
- Phone: +46 (0)46-172805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.