Status:
COMPLETED
Mother Milk as a Eye Drop & Premature Retinopathy
Lead Sponsor:
Baskent University
Collaborating Sponsors:
Konya City Hospital
Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
22-32 years
Phase:
NA
Brief Summary
The aim of this study is to investigate the effect of using breast milk as eye drops on ROP (Retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm babies.
Detailed Description
Study Design: Prospective randomized placebo controlled trial Setting/Participants: Premature babies who are at high risk for retinopathy of prematurity (ROP) during their stay in the neonatal intensi...
Eligibility Criteria
Inclusion
- Infants born between 22 and 32 gestational age weeks or under 1500 gr birth weight.
Exclusion
- Infant death before first examination for ROP
- parents who want to leave from the study
- Contraindications for breast milk use (Active HIV infection, Active tuberculosis, CMV infection)
- Inborn error of metabolism like galactosemia.
- Congenital eye development disorders like agenesis, or situations that do not allow retina examination.
- other lethal congenital molformations
- congenital infections that affect the retina like TORCH infections.
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04883931
Start Date
May 6 2021
End Date
January 20 2022
Last Update
March 16 2022
Active Locations (1)
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1
Baskent University
Konya, Turkey (Türkiye)