Effect of Docosahexaenoic Acid on prevention of retinopathy of prematurity in premature newborn

Determination of the effect of docosahexaenoic acid on the prevention of premature retinopathy in premature infants

A clinical trial with parallel groups, double-blinded, randomized (permuted block randomization), phase 3 on 124 premature newborns, using www.sealedenvelope.com for randomization

This randomized clinical trial study was performed on 124 premature infants weighing less than 1500 g hospitalized in the intensive care unit of Akbarabadi Hospital and Ali Asghar Hospital in Tehran from March to December 2021. Newborns were randomly assigned into 2 groups. In the first intervention group, 1 cc of DHA supplement was prescribed daily for 1 month. In the placebo control group, 1 cc daily was prescribed for 1 month.

Inclusion Criteria: Obtaining parental consent to participate in the study, Premature newborn weighing less than1500 gr; Exclusion Criteria: Infants with asphyxia (umbilical cord pH less than 7 and BE less than -16), IUGR infants, Definitive sepsis (positive blood culture), Newborns with severe congenital chromosomal abnormalities, Newborns with congenital heart disease, Infants with metabolic diseases, Newborns with hypotension need vasodilators

Intervention group: Infants took the DHA supplement (Kelvin kids Drop, manufactured by Zist Takhmir Company, Iran) orally (gavage or PO), 1 cc (40 mg) daily for 1 month. Control group: Newborns took 1 cc of distilled water daily (placebo made by Zist Takhmir Company with the same color and taste as DHA) orally (gavage or PO), 1 cc daily (40 mg) for 1 month.

Retinopathy stage (based on disease severity)

In this study, the block randomization method was used with blocks of sizes six and four. The website https://www.sealedenvelope.com was used to create a randomization list. The blocks were randomly selected using this website and given to a researcher who was not involved in choosing the type of drug. Each random chain generated contains a unique code for concealment. The drug regimen was placed in envelopes according to random chains, and after sealing it on the envelopes, the specific number created by the site was written and the envelopes were randomly placed in a box.

blinding patients: Infants were not aware of the type of medication received due to their condition Physician blinding: DHA and distilled water ( with the same color and taste as DHA) are both oral and given to the newborn by gavage.