The Effect of Co-administered β-Carotene, Vitamin D3, Zinc and Antenatal Steroid Therapy on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hyaline membrane disease
研究概览
简要总结
Hyaline membrane disease, now commonly called respiratory distress syndrome (RDS), and feeding intolerance, which can lead to necrotizing enterocolitis (NEC), are two key morbidities found in premature neonates which resulted in high mortality rate in Indonesia. Cochrane meta-analysis proved that antenatal steroid therapy can reduce the morbidity and mortality rate of premature neonates. But there is still different outcomes and severity of disease in preterm newborn receiving the same dose of antenatal steroid therapy. This raises questions whether there are other factors influencing the development and maturity of lung and gut in preterm newborn, aside from steroid therapy. Vitamin A, D and zinc are already known for their function in fetal lung and gut development. To our best of knowledge, no study has evaluated the effect of these vitamins levels on HMD and feeding intolerance in premature neonates. Therefore, the aim of this study want to evaluate the effect of antenatal steroid therapy versus co-administered β-carotene, vitamin D3, zinc and antenatal steroid therapy on the presence and severity of HMD and feeding intolerance in premature neonates.
详细描述
This study is a randomized controlled trial and held in Cipto Mangunkusumo Hospital.
Pregnant women 28-34 weeks of gestational age, who fulfill the inclusion criteria, divide into two groups. Subjects from both groups receive the hospital protocol of preterm birth, 4 doses of 6 mg of dexamethasone, intravenous 12 hours apart to support lung maturation. Subjects in intervention group receive oral single-dose beta-carotene 25,000 IU, oral single-dose vitamin D3 50,000 IU and oral zinc 50 mg/day for 3 days. The maternal dan cord blood sample are obtained for zinc, vitamin A and 25(OH)D levels before and after intervention. After the premature neonates was born, observation will be done for maximum period of 4 weeks. The presence and severity of HMD and feeding intolerance or NEC will be recorded. Neonates showing any signs of HMD and/or abdominal distension will need to undergo additional chest/abdominal x-ray procedures.
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
- Single (Outcomes Assessor)
盲法说明
The neonates outcomes, hyaline membrane disease and feeding intolerance, will be assessed for maximum period of 4 weeks by doctor who in charge in NICU. They are outside the research team and blind to maternal treatment allocation.
入排标准
- 年龄范围
- 17 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who has preterm birth in 28-34 weeks gestational age
排除标准
- •Multiple pregnancy
- •Drug allergy
- •Fetal congenital malformation
- •Maternal gestational diabetes mellitus
研究组 & 干预措施
Intervention
- beta carotene 25,000 IU
- vitamin D3 50,000 IU
- zinc 50 mg
- dexamethasone 6 mg
干预措施: Beta carotene (Dietary Supplement)
Intervention
- beta carotene 25,000 IU
- vitamin D3 50,000 IU
- zinc 50 mg
- dexamethasone 6 mg
干预措施: Vitamin D3 (Dietary Supplement)
Intervention
- beta carotene 25,000 IU
- vitamin D3 50,000 IU
- zinc 50 mg
- dexamethasone 6 mg
干预措施: Zinc (Dietary Supplement)
Intervention
- beta carotene 25,000 IU
- vitamin D3 50,000 IU
- zinc 50 mg
- dexamethasone 6 mg
干预措施: Dexamethasone (Drug)
Control
dexamethasone 6 mg
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Hyaline membrane disease
时间窗: 1,5 years
The presence and severity of RDS (HMD) will be noted, according to chest X-ray result
次要结局
- Feeding Intolerance(1,5 years)
研究者
Yuyun Lisnawati
dr
Indonesia University