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Mother Milk as a Eye Drop & Premature Retinopathy

Primary Purpose

Retinopathy of Prematurity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Normal Saline
Breast milk
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Retinopathy of Prematurity focused on measuring Breast milk, Retinopathy of Prematurity

Eligibility Criteria

22 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm 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).

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.

Outcomes

Primary Outcome Measures

Retinopathy of Prematurity
Number of participants with any stage of ROP

Secondary Outcome Measures

Retinopathy of Prematurity
Number of participants with laser requiring - severe ROP

Full Information

First Posted
May 7, 2021
Last Updated
March 1, 2022
Sponsor
Baskent University
Collaborators
Konya City Hospital, Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics, Baskent University, Adana Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04883931
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
Collaborators
Konya City Hospital, Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics, Baskent University, Adana Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
Keywords
Breast milk, Retinopathy of Prematurity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Porspective Randomized Placebo Controlled Trail
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
0.5 ml 0.9% normal saline will drop on both eyes twice in a day.
Intervention Type
Biological
Intervention Name(s)
Breast milk
Intervention Description
0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day
Primary Outcome Measure Information:
Title
Retinopathy of Prematurity
Description
Number of participants with any stage of ROP
Time Frame
by 55 weeks post menstrual age
Secondary Outcome Measure Information:
Title
Retinopathy of Prematurity
Description
Number of participants with laser requiring - severe ROP
Time Frame
by 55 weeks post menstrual age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Baskent University
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Mother Milk as a Eye Drop & Premature Retinopathy

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