Screening and result analysis of retinopathy of prematurity in premature and low birth weight neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Incidence rate will be calculated
Study Overview
Brief Summary
• With written and informed consent of the parents
newborn will be examined.
• Detailed history will be taken specially birth weight,
gestational age, any complication during delivery.
• Both the eyes will be examined under torch light for
any gross anterior segment abnormality.
• If direct pupillary reflex is normal then both eyes will
be dilated using diluted Tropicamide(0.4%) +
Phenylephrine(2.5%) eye drops .
• Drops will be instilled three times 10 minutes apart.
While instlling mydriatic eye drop pulse monitor
will be attached to look for pulse and blood
pressure of the child.
• Excess drops immediately blotted to decrease
systemic absorption and side effects.
Retina of both eyes will be examined one by one
using sterile pediatric eye speculum after instilling
1 drop of topical anesthetic eye drop
(paracaine(0.5%)).
• Indirect ophthalmoscopy will be performed using
zeiss indirect ophthalmoscope with 28 D lens.
• All the quadrants of both the eyes will be
examined and charted.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 1.00 Day(s) to 1.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients whose parents are giving written and informed consent for examining their child.
- •New born of gestational age less than 34 weeks or birth weight less than or equal to 2000 g Any baby of gestational age less than 37 weeks or birth weight less than or equal to 2000 g with any of following Sepsis Acute respiratory distress syndrome Multiple blood transfusions Multiple births.
Exclusion Criteria
- •Parents who are not giving written and informed consent.
- •Patient having very poor general condition.
- •Patient having other congenital anomalies of eye.
Outcomes
Primary Outcomes
Incidence rate will be calculated
Time Frame: Incidence rate will be calculated | in different neonate groups. According to their gestational age. 36 week of gestational age will be landmark till that screening must be done.
in different neonate groups.
Time Frame: Incidence rate will be calculated | in different neonate groups. According to their gestational age. 36 week of gestational age will be landmark till that screening must be done.
Secondary Outcomes
No secondary outcomes reported