Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in Blood C-reactive (CRP) Protein
研究概览
简要总结
Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.
The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.
详细描述
30 infants were randomized to receive either poractant or calfactant for Respiratory Distress Syndrome.
Tracheal aspirates were obtained to look for increase in macrophage and blood samples were drawn to look for markers of inflammation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 22 Weeks 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled prior to delivery with signed informed consent and HIPAA by parents
- •Gestational age of less than 35 weeks
- •No maternal chorioamnionitis of other maternal or fetal infection
- •Respiratory Distress Syndrome (RDS) determined by the attending neonatologist that needs to be treated with exogenous surfactant and mechanical ventilation
排除标准
- •Major Birth Defect, Malformation Syndrome
- •Chromosomal or Inherited Metabolic Disorder
- •Proven Presence of an Immunodeficiency
- •Antenatal exposure of illicit substance (e.g., methamphetamines, cocaine, etc., but not marijuana)
- •Birth Asphyxia (cord pH <7.0, Apgar score of 3 or less at 10 minutes of age)
- •HIV or other congenital viral, bacterial or fungal infection
- •Lack of Parental consent of refusal of attending neonatologist to allow participation
- •Discretion of the investigator
- •The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support
研究组 & 干预措施
Calfactant
Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
干预措施: calfactant (Drug)
Poractant Alfa
Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
干预措施: Poractant alfa (Drug)
结局指标
主要结局
Change From Baseline in Blood C-reactive (CRP) Protein
时间窗: baseline, 48 hours
Difference between measurement of CRP at baseline and 48 hours after administration of surfactant
次要结局
- Presence of Pulmonary Hemorrhage(intraoperative)
- Change in Number of Tracheal Macrophages(baseline, 48 hours)