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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04883931

Enrollment

101

Registered

2021-05-12

Start date

2021-05-06

Completion date

2022-01-20

Last updated

2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Keywords

Breast milk, Retinopathy of Prematurity

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).

Interventions

DRUGNormal Saline

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

BIOLOGICALBreast milk

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

Porspective Randomized Placebo Controlled Trail

Eligibility

Sex/Gender

ALL

Age

22 Weeks to 32 Weeks

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Retinopathy of Prematurity	by 55 weeks post menstrual age	Number of participants with any stage of ROP

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026