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Completed

NCT Number: NCT04883931

Mother Milk as a Eye Drop & Premature Retinopathy

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

22 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Konya, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

normal saline

Drug

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

Breast milk

Biological

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

Primary outcomes

  1. Retinopathy of Prematurity

    Time frame: by 55 weeks post menstrual age

    Number of participants with any stage of ROP

Secondary outcomes

  1. Retinopathy of Prematurity

    Time frame: by 55 weeks post menstrual age

    Number of participants with laser requiring - severe ROP

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Collaborators

  • Konya City Hospital
  • Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 12, 2021
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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