None listed
Conditions
Brief summary
To date, there has not been an evaluation of a suitable device to administer microdoses to preterm infants. The nanodrop eye drop device has been evaluated in adults and children, but not yet evaluated in preterm infants.
Interventions
Intervention type: Silicone Device 2
Intervention description: A silicone tip will be attached to the top of eye drop bottle. Neonatal nursing staff will administer phenylephrine 1% and cyclopentolate 0.2% eye drops to preterm infants to prepare the eye for retinopathy of prematurity eye examinations. One set of eye drops will be administered 30 to 45 min before the eye examination. Up to two more doses can be administered (15 to 20 min apart) if needed, at the request of the ophthalmologist
Intervention type: Silicone Device 2 Intervention description: A silicone tip will be attached to the top of eye drop bottle. Neonatal nursing staff will administer phenylephrine 1% and cyclopentolate 0.2% eye drops to preterm infants to prepare the eye for retinopathy of prematurity eye examinations. One set of eye drops will be administered 30 to 45 min before the eye examination. Up to two more doses can be administered (15 to 20 min apart) if needed, at the request of the ophthalmologist. Administration of eye drops will be recorded to confirm dose administration.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
23 Weeks to 40 Weeks
Healthy volunteers
No
Inclusion criteria
All preterm infants that meet the Dunedin Hospital Neonatal Intensive Care Unit ROP screening criteria (e.g., 30+6 weeks gestational age and / or 1250 g birth weight) in keeping with national guidelines.
Exclusion criteria
Preterm infants who do not meet the inclusion criteria for ROPEE. Preterm infants who are contraindicated to phenylephrine and / or cyclopentolate. Preterm infants who have an eye infection.
Outcome results
None listed