Effect of Vitamin E Supplementation on Oxidative Stress and Retinopathy of Prematurity in Preterm Infants <1500 g: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Incidence of retinopathy of prematurity
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 3 Days 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn weight < 1500 g
- •Diagnosed respiratory distress syndrome (RDS)
- •Patients who required mechanical ventilation or CPAP
排除标准
- •Congenital malformations
- •Rh incompatibility
- •Non-immune or immune hydrops fetalis
- •Intraventricular haemorrhage III/IV grade
研究组 & 干预措施
Treatment A
Group A: received 12.5 IU of vitamin E orally every 12 hours, from 72 h of birth to 28 days old.
干预措施: Vitamin E (Drug)
Treatment B
Group B: received 12.5 IU of placebo orally every 12 hours, from 72 hours of birth to 28 days old.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of retinopathy of prematurity
时间窗: For the first retinopathy diagnosis, ophthalmological evaluation was performed at 28 days of birth.
Retinopathy of prematurity was classified according to the International Classification of Retinopathy of Prematurity revisited 2005.
次要结局
- Incidence of bronchopulmonary dysplasia (BPD)(Incidence of BPD was measured in each participant at 28 days old.)
- Severity of bronchopulmonary dysplasia (BPD)(Severity of BPD was measured at corrected 36 weeks' gestational age.)
研究者
Silvia Romero-Maldonado
Principal Investigator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes