Mother Milk as a Eye Drop & Premature Retinopathy

NCT04883931 | Completed

• 1 other identifier: KA21/65
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity

Keywords

Breast milk; Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• Retinopathy of Prematurity

  Number of participants with any stage of ROP

  by 55 weeks post menstrual age

Secondary Outcomes (1)

• Retinopathy of Prematurity

  by 55 weeks post menstrual age

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Normal Saline DRUG

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

Placebo group

Breast milk BIOLOGICAL

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

Intervention group

Eligibility Criteria

• Age: 22 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University: lead
• Konya City Hospital: collaborator
• Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics: collaborator

Study Sites (1)

Baskent University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Saline Solution; Milk, Human

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Porspective Randomized Placebo Controlled Trail

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: May 6, 2021
• Primary Completion: November 30, 2021
• Study Completion: January 20, 2022
• Last Updated: March 16, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)