Mother Milk as a Eye Drop & Premature Retinopathy

Study Overview
=================
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 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).

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

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Drug: Normal Saline
* Biological: Breast milk


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 22 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Porspective Randomized Placebo Controlled Trail
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>With in 48-72 hour after birth, infants will receive 0.5 ml breast milk for own mother as a eye drop twice in a day until the discharge or need for laser coagulation. Fresh milk was used as eye drop ( not exceed 6 hours after milking). | Biological: Breast milk<br>* 0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day<br>|
| Placebo Comparator: Placebo group<br>With in 48-72 hour after birth, infants will receive 0.5 ml 0.9% normal saline as a eye drop twice in a day until the discharge or need for laser coagulation. | Drug: Normal Saline<br>* 0.5 ml 0.9% normal saline will drop on both eyes twice in a day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinopathy of Prematurity | Number of participants with any stage of ROP | by 55 weeks post menstrual age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinopathy of Prematurity | Number of participants with laser requiring - severe ROP | by 55 weeks post menstrual age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast milk, Retinopathy of Prematurity