Mother Milk as a Eye Drop & Premature Retinopathy

Baskent University101 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

101

Conditions

Retinopathy of Prematurity

Interventions

Normal SalineDRUG

0.5 ml 0.9% normal saline will drop on both eyes twice in a day.

Breast milkBIOLOGICAL

0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day

Eligibility

Sex: ALLMin age: 22 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Infants born between 22 and 32 gestational age weeks or under 1500 gr birth weight. Exclusion Criteria: * 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.

Locations (1)

Baskent University

Konya, Turkey (Türkiye)

Outcomes

Primary Outcomes

Retinopathy of Prematurity

Number of participants with any stage of ROP

Time frame: by 55 weeks post menstrual age

Secondary Outcomes

Retinopathy of Prematurity

Number of participants with laser requiring - severe ROP

Time frame: by 55 weeks post menstrual age

Data from ClinicalTrials.gov

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