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IRCT20211226053528N1 IRCT 2022-01-31 Iran University of Medical Sciences Effect of Docosahexaenoic Acid on ROP in premature newborn Effect of Docosahexaenoic Acid on prevention of retinopathy of prematurity in premature newborn 2021-03-21 anticipated 124 Complete https://irct.ir/trial/60882 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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 description: 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. 3 Retinopathy of prematurity. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Fateme Jafarnazari
Aliasghar Children's Hospital, No.193, Modares Highway, zafar St
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 khosravi.n@iums.ac.ir Iran University of Medical Sciences scientific Fateme Jafarnazari
Aliasghar Children's Hospital, No.193, Modares Highway, zafar St
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 khosravi.n@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Obtaining parental consent to participate in the study Premature newborn weighing less than1500 gr 1 day 14 days Both 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 H35.1 Retinopathy of prematurity Prevention Placebo 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). Timepoint: before intervention and 1month after intervention. Method of measurement: Based on the severity of the disease (1-5 stages) by an ophthalmologist. Iran University of Medical Sciences Approved 2021-02-13 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences,5th Floor, Hemat Highway, Next to the Milad Tower Tehran Tehran Iran (Islamic Republic of)