Pilot Study of Dornase Alfa (Pulmozyme) Therapy for Acquired Ventilator Associated Infection in Preterm and Late Preterm Infants in the Neonatal Intensive Care Unit
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Percent Reduction in Oxygen Requirement From Baseline
研究概览
简要总结
To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator associated pulmonary infections. Dornase alfa has been effective in the treatment of pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The bacteria causing pulmonary infections in cystic fibrosis patients is similar to those infecting preterm infants. The investigators expect that dornase alfa therapy will improve recovery from ventilator associated pulmonary infections in preterm infants.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants less than 38 weeks gestation and over 7 days of age
- •infants with a ventilator associated pulmonary infection, defined as intubated infants who have moderate to heavy White Blood Cells (WBCs) on tracheal aspirate, organisms on tracheal aspirate gram stain, a positive endotracheal tube culture, a chest x-ray with infiltrate, consolidation or atelectasis, an increase in oxygen (FiO2) requirement and whom the clinical team decides to treat with systemic antibiotic therapy
排除标准
- •Extremely ill infants not expected to survive
- •Critically ill infants requiring high frequency ventilation
- •Infants with congenital pneumonia
- •Infants with congenital malformations of the respiratory system (e.g. Congenital diaphragmatic hernia, cystic adenomatoid malformation or tracheo-esophageal fistula) Cyanotic congenital heart disease, chromosomal abnormalities and infants with a positive newborn screen for cystic fibrosis
研究组 & 干预措施
Sham placebo
No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.
干预措施: Placebo (Drug)
Dornase alfa
Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
干预措施: Dornase alfa (Drug)
结局指标
主要结局
Percent Reduction in Oxygen Requirement From Baseline
时间窗: First week of treatment or extubation
Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation
次要结局
- Elimination of White Blood Cells and Bacteria From Tracheal Aspirate(During first week of treatment or until extubation whichever is earlier)
- Number of Infants Requiring Ventilator Support(7 days)
研究者
Melissa Scala
Assistant Professor of Pediatrics, Department of Neonatology
Georgetown University