Effect of Sustained Lung Inflation During CPAP in Preterm Neonates With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Serum concentration of cytokines
研究概览
简要总结
Neonatal respiratory distress syndrome (RDS) is the most common cause of respiratory failure in the first few days in life. It is characterized by the tendency of alveoli and terminal bronchioles to collapse due to the lack of surfactant. RDS is inversely related to gestational age and remains a dominant clinical problem encountered among preterm infants.
The reduction in tidal volume secondary to alveolar collapse may result in alveolar derecruitment, cyclic opening and closing of atelectatic alveoli and distal small airways leading to inflammation and lung injury). On the other hand, the use of high positive end expiratory pressure (PEEP) may be associated with excessive lung parenchyma strain and unfavorable hemodynamic effects. Therefore, lung recruitment maneuvers have been proposed and used to open collapsed lung while managing with low pressure PEEP. However, the best recruitment maneuver technique is currently unknown.
Proinflammatory cytokines are synthesized by alveolar macrophages, type II pneumocytes and other local pulmonary cells causing inflammation that starts a cascade leading to lung injury. Nevertheless, they are released systemically and can lead to injury of other organs.
This study aims to measure inflammatory cytokines in the serum of premature infants who receive and do not receive sustained lung inflation. The study hypothesis is that, in premature infants supported with CPAP, the use of sustained inflation is associated with decreased inflammatory biomarkers and improved respiratory outcomes.
The study includes infants with gestational age of 28-24 weeks during the first 6 hours of life who will be randomly assigned to either receive (or do not receive) sustained inflations. Serum concentrations of cytokines (IL-6, IL-8, IL-1β and TNF-α) will be measured at enrollment and at 96 hours. The primary outcome of this study will be the change in serum cytokine concentrations after intervention in both groups. Clinical respiratory outcomes will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
All laboratory testing will be performed by investigators who are not aware of group assignment.
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 28 weeks (and 0 days) and 34 weeks (and 6 days)
- •Postnatal age <6 hours
- •Respiratory distress syndrome diagnosed by both clinical findings of subcostal retractions, tachypnea (>70 breaths/min), the need for respiratory support to maintain oxygen saturation > 87% and X-ray findings of RDS
- •Application of early CPAP <6 hours of age
- •Oxygen requirement (FiO2 >30% to maintain preductal saturation 87% - 93%)
排除标准
- •Before enrollment: infants will not be considered in the study if any of the following conditions exists: major congenital anomalies, severe hemodynamic instability indicative of early septicemia, use of inotropes, severe metabolic acidemia with base deficit >12 mEq/dl, frequent apnea / bradycardia (6 episodes per day with HR <100 or 2 episodes per day with HR<60 requiring bag-and-mask ventilation), maternal chorioamnionitis (fever >38 degree Celsius with abdominal tenderness) and PPROM >18 hours, and perinatal hypoxia (Apgar score < 6 at 5 minutes)
- •After enrollment: infants will be eliminated from the study if the initial blood culture on admission is positive.
研究组 & 干预措施
Group A
Infants in the group receive CPAP for respiratory support in the delivery room. In addition, they receive a total of 15 sustained lung inflations in the first 96 hours of life; 6 in the first day, 3 in the second day, 3 in the third day and 3 in the forth day of life.
干预措施: Sustained lung inflation (Procedure)
Group B
Infants in the group receive CPAP for respiratory support in the delivery room. No sustained lung inflation will be applied.
干预措施: Continuous positive airway pressure (CPAP) (Procedure)
Group C
Infants in this group are intubated in the delivery room and supported with mechanical ventilation.
干预措施: Mechanical ventilation (Procedure)
结局指标
主要结局
Serum concentration of cytokines
时间窗: At 96 hours of life
IL-6, IL-8, IL-1β, - TNF-α and elastase will be measured in all subjects in group, group B, and group C.
次要结局
- Oxygen requirement(At 96 hours of life)
研究者
Ghada Ibrahim Gad
Professor of Pediatrics
Ain Shams University