Mother Milk as a Eye Drop & Premature Retinopathy

March 1, 2022 updated by: Musa Silahli, Baskent University

The Effect of Using Breast Milk as a Topical Ophthalmic Drop on Retinopathy of Prematurity. Randomized Placebo-controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Başkent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
Biological: Breast milk
0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day
PLACEBO_COMPARATOR: 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.
Drug: Normal Saline
0.5 ml 0.9% normal saline will drop on both eyes twice in a day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Collaborators

Konya City Hospital
Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics
Baskent University, Adana Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 6, 2021

Primary Completion (ACTUAL)

November 30, 2021

Study Completion (ACTUAL)

January 20, 2022

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (ACTUAL)

May 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA21/65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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