Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Presence or absence of acute clinical deterioration up to 60 minutes after study intervention
研究概览
简要总结
This clinical trial is being done to evaluate the safety and clinical response of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.
详细描述
Primary Objective
• To evaluate safety of late surfactant therapy with budesonide in extremely preterm infants.
Secondary Objectives
- To evaluate the oxygenation response to late surfactant therapy with budesonide in extremely preterm infants at 48 hours and 7 days after completion of the study intervention
- To evaluate respiratory outcomes following administration of late surfactant therapy with budesonide
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
- None
入排标准
- 年龄范围
- 7 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonate Inclusion Criteria:
- •Gestational age 22 0/7 to 28 6/7 weeks at birth
- •Age 7-14 days
- •Need invasive mechanical ventilatory support and a Fraction of Inspired Oxygen (FiO2) greater than or equal to 0.3
- •Birthing Parent Inclusion Criteria:
- •Have a baby who meets neonate eligibility criteria and enrolls in the study.
排除标准
- •Major congenital anomalies including congenital lung malformations and congenital diaphragmatic hernia and/or genetic disorders
- •Alternative, acute clinical etiology of respiratory deterioration or increased ventilatory requirements (e.g., sepsis, pneumonia, etc.)
- •History of pulmonary hemorrhage
- •Antibiotic use within 48 hours
- •Indomethacin or Ibuprofen use within 72 hours
- •Prior treatment with corticosteroids for prevention of lung disease
- •Not expected to survive for greater than 7 days at enrollment
- •Determined to be unstable by the clinical team
- •Enrolled in a conflicting clinical trial
- •Have a birth parent aged less than 18 years
- •Parent/guardian is unable to provide parental permission in English or Spanish
研究组 & 干预措施
Premature babies: Study Intervention
Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life (targeting N=12 participants completing study to 7 days post-intervention)
干预措施: Calfactant (Drug)
Premature babies: Study Intervention
Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life (targeting N=12 participants completing study to 7 days post-intervention)
干预措施: Budesonide (Drug)
Premature babies: Standard of Care
Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life (targeting N=12 participants completing study to 10 days post-randomization)
结局指标
主要结局
Presence or absence of acute clinical deterioration up to 60 minutes after study intervention
时间窗: up to 60 minutes after study intervention (intervention received within 14 days of life (DOL))
Presence or absence of acute clinical deterioration - defined as desaturation less than 80 percent and/or bradycardia less than 100 beats per minute (bpm) - during the study intervention and up to 60 minutes after study intervention.
Occurrence of pulmonary hemorrhages up to 48 hours after completion of study intervention
时间窗: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
A yes or no question of whether pulmonary hemorrhage (bleeding in lungs) was observed in the endotracheal tube from baseline to 48 hours after completion of study intervention.
Presence or absence of severe acute clinical deterioration up to 60 minutes after study intervention
时间窗: up to 60 minutes after study intervention (intervention received within 14 DOL)
Presence or absence of severe acute clinical deterioration - defined as desaturation less than 60 percent and/or bradycardia less than 80 bpm - during the study intervention and up to 60 minutes after study intervention.
Occurrence of pneumothorax needing evacuation up to 48 hours after completion of study intervention
时间窗: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
A yes or no question of whether there was pneumothorax (air in the pleural cavity) detected via chest x-ray, needing evacuation from baseline to 48 hours after completion of study intervention
次要结局
- Death or Grade 3 Bronchopulmonary Dysplasia (BPD) by 36 0/7 weeks Post-Menstrual Age (PMA)(up to 36 0/7 weeks PMA)
- Change in Respiratory Severity Score (RSS)(Baseline to 7 days post-intervention (intervention received within 14 DOL))
- Days of mechanical ventilation by 36 0/7 weeks PMA(up to 36 0/7 weeks PMA)