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| Name | Class |
|---|---|
| Konya City Hospital | OTHER |
| Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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). |
|
| Placebo group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline | Drug | 0.5 ml 0.9% normal saline will drop on both eyes twice in a day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Retinopathy of Prematurity | Number of participants with any stage of ROP | by 55 weeks post menstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| Retinopathy of Prematurity | Number of participants with laser requiring - severe ROP | by 55 weeks post menstrual age |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baskent University | Konya | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Porspective Randomized Placebo Controlled Trail
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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.
| Breast milk |
| Biological |
0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day |
|
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008892 |
| Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |