Mother Milk as a Eye Drop & Premature Retinopathy

Not Applicable

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Biological: Breast milk; Drug: Normal Saline

• Registration Number: NCT04883931
• Lead Sponsor: Baskent University

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).

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-06
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-12
• Primary Completion: 2021-11-30
• Study Completion: 2022-01-20
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Infants born between 22 and 32 gestational age weeks or under 1500 gr birth weight.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Breast milk	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).
Placebo group	Normal Saline	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.

Primary Outcome Measures

Name	Time	Method
Retinopathy of Prematurity	by 55 weeks post menstrual age	Number of participants with any stage of ROP

Secondary Outcome Measures

Name	Time	Method
Retinopathy of Prematurity	by 55 weeks post menstrual age	Number of participants with laser requiring - severe ROP

Trial Locations

Locations (1)

Baskent University; 🇹🇷 Konya, Turkey