NCT04883931

Mother Milk as a Eye Drop & Premature Retinopathy

The Effect of Using Breast Milk as a Topical Ophthalmic Drop on Retinopathy of Prematurity. Randomized Placebo-controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Baskent University · Academic / Other
• Sex: All
• Age: 22 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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 intensive care unit (NICU). The study will be carried out at Baskent University and it is planned that 70 participants will be included in the study. Study Interventions and Measures: After the randomization of the patients, 0.5 ml breast milk of the babies' own mothers will drop on the eye to the intervention group twice a day. IN the control group, %0.9 normal saline will drop as same amount. Primary outcome is any stage of ROP, secondary outcome is severe ROP (laser requiring ROP).

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
DRUG	Normal Saline	0.5 ml 0.9% normal saline will drop on both eyes twice in a day.
BIOLOGICAL	Breast milk	0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day

Timeline

• Start date: 2021-05-06
• Primary completion: 2021-11-30
• Completion: 2022-01-20
• First posted: 2021-05-12
• Last updated: 2022-03-16

Locations

1 site across 1 country: Turkey (Türkiye)