The Effect of Enteral Organic Extra Virgin Olive Oil Supplementation in Premature Babies on Postnatal Growth and Premature Morbidities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of patients who completed the study
研究概览
简要总结
It is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. In the intervention group, babies will take 1 ml/kg/day of the study product (ULTRA PREMIUM) after full enteral feeding.
Supplementation will continue until discharge or the 36th week. Blood samples will be taken for serum Total antioxidant capacity and Malondialdehyde levels before the intervention and on the 14th day of the control group. At the end of the study, serum will be taken again for control values.
Daily lipid intake amounts will be recorded through breast milk analysis. Lipid profile will be monitored weekly The growth parameters of babies will be monitored daily It will be evaluated at the end of the study in terms of ROP, BPD, and NEC. At the end of the study, the data of babies in both groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Days 至 40 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature babies born at 32 weeks or less
- •Babies who tolerate full enteral feeding at the before end of the second week
- •Babies given consent by their parents -
排除标准
- •Having a congenital or genetic anomaly
研究组 & 干预措施
Olive oil group
Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil
干预措施: Extra virgin organic olive oil (ULTRA PREMIUM) (Dietary Supplement)
Control group
结局指标
主要结局
Number of patients who completed the study
时间窗: 15 months
To enrolment of 40 babies in the study in both groups
Postnatal growth retardation rates
时间窗: 18 months
Daily weight intake amounts of babies in both groups
次要结局
- Frequency and severity of retinopathy of prematurity(18 months)
研究者
Bayram Ali DORUM
Head of Division of Neonatology, Associate Professor
Bursa City Hospital