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

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Status: Completed

Conditions: Retinopathy of Prematurity

Treatments: Drug: Placebo; Drug: Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT03274596

212250-10231

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 90 patients

Sex: All

Ages: 3 to 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Treatment A

Active Comparator group

Description:

Group A: received 12.5 IU of vitamin E orally every 12 hours, from 72 h of birth to 28 days old.

Treatment:

Drug: Vitamin E

Treatment B

Placebo Comparator group

Description:

Group B: received 12.5 IU of placebo orally every 12 hours, from 72 hours of birth to 28 days old.

Treatment:

Drug: Placebo