Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome
研究概览
简要总结
To research the effect of vitamin A to newborn respiratory distress syndrome by intratracheal administration with surfactant.
详细描述
Chronic lung disease (CLD) of prematurity is the major cause of long-term disability of extremely LBW (ELBW) premature infants, and it is the most cost consumptive disease in Neonatal Intensive Care Unit graduates. Vitamin A plays an important role in the development of premature lung. Nevertheless, premature infants are prone to vitamin A deficiency. Oral supplementation of vitamin A does not alter the incidence of CLD in ELBW infants. Intramuscular administration of vitamin A reduced the incidence of CLD. The treatment is considered painful and this way is not routinely practiced. Vitamin A is systemically bioavailable after intratracheal administration with surfactant in an animal model of newborn respiratory distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Newborn infants with birth weight >500 gm.
- •2.Gestational age >24 completed weeks.
- •3.Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
- •4.No known lethal congenital anomaly or genetic syndromes.
- •5.Signed parental informed consent
排除标准
- •1.Considered non-viable by clinician (decision not to administer effective therapies)
- •2.Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- •3.Infants known to require surgical treatment
- •4.Abnormalities of the upper and lower airways
- •5.Neuromuscular disorders
- •6.Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube
研究组 & 干预措施
I=surfactant
Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
干预措施: surfactant (Drug)
II=surfactant+vitamin A
Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome
干预措施: surfactant+vitamin A (Drug)
结局指标
主要结局
Intratracheal Vitamin A Administration with Surfactant for Newborn Respiratory Distress Syndrome
时间窗: 1 year
get the date of infants' reflects with Intratracheal Vitamin A Administration
次要结局
- Overall clinical outcomes at Newborn Infants With Respiratory Distress Syndrome(13 months)