An observational study in Retinopathy of Prematurity, sponsored by Bulent Ecevit University. Completed. Open to participants aged 32 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Bulent Ecevit University · Observational
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Because of the neonatologists reported that some infants had suffered from vomiting, bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination in the intensive care unit. The investigators observed the pupil dilation effects and side effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop combination which the investigators routinely used in ROP examination.
Purpose: To determine effect and vital change after topical application of phenylephrine 2.5% and tropicamide 0.5% three times for retinopathy of prematurity (ROP) examination in preterm infants.
Methods: Pupillary diameter, blood pressure, pulse rate, and oxygen saturation were monitored before, and after up to 24 hours 60 ROP screening examinations.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
This study's enrollment of 60 is below the median of 175 across 57 observational studies indexed under Retinopathy of Prematurity.
Browse Retinopathy of Prematurity studies →Bulent Ecevit University is the lead sponsor of 48 studies on the registry; 3 are open to participants now.
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tertiary health center in the west Black Sea region
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Exclusion Criteria:
to investigate side effects of eye drops used
Also known as: Tropicamide and mydfline used
The mean pupillary diameter
will be measured with a ruler after 60 minutes instillation of mydriatic
Time frame: an average of 1 year
No study locations are listed for this record.
Plan to share: Undecided
Ran from Jan 2016 to primary completion in Oct 2017, 21 months.
Of 25 observational studies under Retinopathy of Prematurity, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's 21 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Bulent Ecevit University