Brief Title
Mother Milk as a Eye Drop & Premature Retinopathy
Official Title
The Effect of Using Breast Milk as a Topical Ophthalmic Drop on Retinopathy of Prematurity. Randomized Placebo-controlled Trial.
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.
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
Primary Outcome
Retinopathy of Prematurity
Secondary Outcome
Retinopathy of Prematurity
Condition
Retinopathy of Prematurity
Intervention
Normal Saline
Study Arms / Comparison Groups
Intervention group
Description: 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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
101
Start Date
May 6, 2021
Completion Date
January 20, 2022
Primary Completion Date
November 30, 2021
Eligibility 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.
Gender
All
Ages
22 Weeks - 32 Weeks
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT04883931
Organization ID
KA21/65
Responsible Party
Principal Investigator
Study Sponsor
Baskent University
Collaborators
Konya City Hospital
Study Sponsor
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Verification Date
May 2021