Evaluation of Pulmonary Mechanics in Preterm Infant Treated With Sustained Lung Inflation at Birth
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Reactance (Xrs) values measured by the forced oscillation technique (FOT)
研究概览
简要总结
Lung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in the delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a precocious functional residual capacity (FRC) both in animal and human studies. SLI associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV).
Further studies are required to evaluate the clinical utility of this maneuver. The ability to monitor what happens to the lungs while applying different recruitment maneuvers in preterm infants would allow the definition of a procedure that allows optimal assistance to improve the FRC. One promising approach is provided by the forced oscillation technique (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied to the airway opening and the mechanical response of the respiratory system is studied by means of the total respiratory input impedance (Zin). Zin is a complex number that can be expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs). Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to changes in the mechanics of lung periphery and provides accurate information about lung volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the assessment of lung function in newborns submitted to SLI at birth. The investigators hypothesized that the application in the delivery room of the SLI in the preterm infant is effective in achieving a greater FRC and therefore a greater value of Xrs compared to a control group not treated with the SLI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age (GA) at least 25 weeks but less than 36 completed weeks by best obstetrical estimate
排除标准
- •Refusal of antenatal informed consent
- •Known major anomalies, pulmonary hypoplasia
- •Severe perinatal suffering
结局指标
主要结局
Change in Reactance (Xrs) values measured by the forced oscillation technique (FOT)
时间窗: Baseline and at 5 minutes of life (that is, before and at the end of the SLI)
次要结局
- Number of surfactant doses(During hospitalization - up to 36 weeks Post Menstrual Age (PMA))
- Retinopathy of prematurity (ROP) stage 3 or greater requiring treatment(40 weeks Post Menstrual Age (PMA))
- Incidence of Patent Ductus Arteriosus (PDA) requiring treatment(During hospitalization - up to 36 weeks Post Menstrual Age (PMA))
- Incidence of Bronchopulmonary dysplasia(36 weeks Post Menstrual Age (PMA))
- Need for intubation within the first 72 hours of life(72 hours of life)
- Death in hospital(During hospitalization - up to 40 weeks Post Menstrual Age (PMA))
- Duration of respiratory support (ventilation, CPAP, supplemental oxygen)(During hospitalization - up to 36 weeks Post Menstrual Age (PMA))
- Length of hospital stay(Average discharge between 36 - 40 weeks PMA)
- Incidence of Intracranial Hemorrhages (ICH)(During hospitalization- up to 40 weeks Post Menstrual Age (PMA))
研究者
Mariarosa Colnaghi
Medical doctor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico