Mother Milk as a Eye Drop & Premature Retinopathy

• ClinicalTrials.gov Identifier: NCT04883931
• Recruitment Status: Completed
• First Posted: May 12, 2021
• Last Update Posted: March 16, 2022
• Sponsor: Baskent University
• Collaborators: Konya City Hospital; Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics; Baskent University, Adana Hospital
• Information provided by (Responsible Party): Musa Silahli, Baskent University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Retinopathy of Prematurity	Drug: Normal Saline; Biological: Breast milk	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Porspective Randomized Placebo Controlled Trail
• Masking: Double (Participant, 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.
• Primary Purpose: Prevention
• Official Title: The Effect of Using Breast Milk as a Topical Ophthalmic Drop on Retinopathy of Prematurity. Randomized Placebo-controlled Trial.
• Actual Study Start Date: May 6, 2021
• Actual Primary Completion Date: November 30, 2021
• Actual Study Completion Date: January 20, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Retinopathy of Prematurity [ Time Frame: by 55 weeks post menstrual age ]
   Number of participants with any stage of ROP

Secondary Outcome Measures :

1. Retinopathy of Prematurity [ Time Frame: by 55 weeks post menstrual age ]
   Number of participants with laser requiring - severe ROP

Eligibility Criteria

• Ages Eligible for Study: 22 Weeks to 32 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Turkey

Baskent University

Konya, Turkey

Sponsors and Collaborators

Baskent University

Konya City Hospital

Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics

Baskent University, Adana Hospital

More Information

• Responsible Party: Musa Silahli, Principal Investigator, Baskent University
• ClinicalTrials.gov Identifier: NCT04883931
• Other Study ID Numbers: KA21/65
• First Posted: May 12, 2021
• Last Update Posted: March 16, 2022
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Musa Silahli, Baskent University:

Breast milk; Retinopathy of Prematurity

Additional relevant MeSH terms:

Retinal Diseases; Retinopathy of Prematurity; Premature Birth; Eye Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases