Mother Milk as a Eye Drop & Premature Retinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2022-01-20

Brief Summary

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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.

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Detailed Description

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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

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Retinopathy of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Porspective Randomized Placebo Controlled Trail

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participant and Ophthalmologist who is the responsible the follow -up the ROP stages will be blind in the study. The neonatologist who is responsible for the care and follow-up of the patients will not be blind.

Study Groups

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Intervention group

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).

Group Type EXPERIMENTAL

Breast milk

Intervention Type BIOLOGICAL

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

Placebo group

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.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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

Interventions

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Normal Saline

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

Intervention Type DRUG

Breast milk

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

22 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No