Mother Milk as a Eye Drop & Premature Retinopathy

Baskent University

Status: Completed

Conditions: Retinopathy of Prematurity

Treatments: Drug: Normal Saline; Biological: Breast milk

Study type: Interventional

Funder types: Other

Identifiers

NCT04883931

KA21/65

Details and patient eligibility

About

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.

Full 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).

Enrollment: 101 patients

Sex: All

Ages: 22 to 32 weeks old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

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).

Treatment:

Biological: Breast milk

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal Saline