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Study aim
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Investigating the effectiveness of adding oral omega-3 and zinc to the diet of premature neonates in preventing the occurrence of retinopathy of prematurity (ROP).
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Design
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A clinical trial with a control group, double-blind, randomized by block method, phase 3, on 300 patients.
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Settings and conduct
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Premature neonate are fed 250 mg of omega-3 supplements for 28 days. In the zinc group, the amount of zinc in the oral supplement will be increased to 2 mg/kg. In the Omega 3 and Zinc groups, they receive the same dose as the previous two groups. In the placebo group, feeding is done with normal saline serum.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Premature neonates with a gestational age of less than 32 weeks - Premature neonates with a birth weight of less than 1500 grams - Breast feeding ; Exclusion criteria: Major congenital anomalies - Sepsis or significant comorbidities
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Intervention groups
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In this study, the infants included in the study were in one of the four enteral feeding groups with a high dose of omega-3 (omega-3 group), a high-dose zinc group (zinc group), and a group fed with omega-3 and zinc (omega-3 and zinc group). The group fed with placebo (control group) will be placed
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Main outcome variables
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The primary outcome is the incidence of ROP requiring treatment, which will be by regular ophthalmological examinations with an ophthalmoscope according to the modified protocol at 1 month of age and every 2 weeks thereafter at the physician's discretion. Secondary outcomes include severity of ROP, need for laser therapy or surgery, and visual acuity