Mother Milk as a Eye Drop & Premature Retinopathy

Retinopathy of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883931
• Other study ID #: KA21/65
• Status: Completed
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: January 20, 2022

Study information

• Verified date: May 2021
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 20, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Weeks to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Normal Saline
0.5 ml 0.9% normal saline will drop on both eyes twice in a day.

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

Locations

Country	Name	City	State
Turkey	Baskent University	Konya

Sponsors (4)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinopathy of Prematurity	Number of participants with any stage of ROP	by 55 weeks post menstrual age
Secondary	Retinopathy of Prematurity	Number of participants with laser requiring - severe ROP	by 55 weeks post menstrual age