Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.

Effect of Vitamin E Supplementation on Oxidative Stress and Retinopathy of Prematurity in Preterm Infants <1500 g: A Randomized Clinical Trial.

The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand however its use was stopped because of its association with sepsis and enterocolitis caused by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP, without the previously used excipients.

Antioxidant defence mechanisms include cellular and extracellular enzymes. Vitamin E is the main fat-soluble vitamin responsible for the protection of cell membranes against peroxidation, thus, it protects polyunsaturated fatty acids from peroxidation which is a step in the pathogenesis of ROP. Previous research on the roles of vitamin E, in the prevention of BPD and ROP was halted because of complications involving sepsis and necrotising enterocolitis. These complications were caused by the compositions of vitamin E oral presentations, which contain polyethylene glycol, propylene glycol, ethanol and, polysorbate 80. These substances, which are used as excipients, may generate adverse effects in premature newborns. These preparations were not used in this project to avoid the development of necrotising enterocolitis, and because these formulations are not commercially available in Mexico. The infants were randomly assigned to one of two groups using a computerized random number generator sequence; this process was handled by the hospital pharmacy staff. The treated group, received vitamin E 12.5 IU orally every 12 hours, from 72 h after birth until 28 days of age, the first blood sample collected from the newborns before the intervention was considered the baseline, and subsequent samples were obtained at 15 and 28 days of age. Control group: received orally sterile water (placebo)

participants were randomly assigned to one of two treatmenst (A and B) using a computarized random number generator sequence; this process was handled by the hospital pharmacy staff. Group A: received vitamin E 12.5 IU orally every 12 hours, from 72 h after birth until 28 days of age, Group B: received orally sterile water (placebo) orally every 12 hours, from 72 h after birth until 28 days of age,

The placebo was made by a pharmacologist and was the only person who knows the treatment of A and B. The placebo was administered by nursing staff and had the same appearance and amount as vitamin E. Neither the parents of the participants nor the researchers involved in the care or analysis of the data knew the content of the treatment and B until the end of the study.

Retinopathy of prematurity was classified according to the International Classification of Retinopathy of Prematurity revisited 2005.

BPD diagnosis was established according to the National Institute of Child Health and Human Development (NICHD) Workshop summary.

Severity was classified into one of three stages: mild, when the patient did not required oxygen; moderate, when the patient required 30% oxygen; and severe when the patient required >30% oxygen, had nasal continuous positive airway pressure (CPAP), or mechanical ventilation.

Inclusion Criteria: Newborn weight < 1500 g Diagnosed respiratory distress syndrome (RDS) Patients who required mechanical ventilation or CPAP Exclusion Criteria: Congenital malformations Rh incompatibility Non-immune or immune hydrops fetalis Intraventricular haemorrhage III/IV grade

Romero-Maldonado S, Montoya-Estrada A, Reyes-Munoz E, Guzman-Grenfell AM, Torres-Ramos YD, Sanchez-Mendez MD, Tolentino-Dolores M, Salgado-Valladares MB, Belmont-Gomez A, Najera N, Ceballos G, Cardona-Perez JA, Hicks JJ, Mancilla-Ramirez J. Efficacy of water-based vitamin E solution versus placebo in the prevention of retinopathy of prematurity in very low birth weight infants: A randomized clinical trial. Medicine (Baltimore). 2021 Aug 6;100(31):e26765. doi: 10.1097/MD.0000000000026765.