Electrical Impedance Tomography and Lung Ultrasound Score in Early Prediction of Bronchopulmonary Dysplasia in Preterm and Very Low Birth Weight Infants.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The prognostic value of homogeneity of ventilation assessed with EIT
研究概览
简要总结
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation. Identifying this characteristic from the first days of life by using EIT could, in the future, optimize non-invasive ventilation strategies as early as possible, such as lung recruitment manoeuvres, which are currently mainly used during invasive mechanical ventilation. In addition, comparing the LUS scores and homogeneity parameters derived from the EIT may help to further confirm the role of semi-quantitative lung ultrasound as a rapid, non-invasive, and readily available tool in NICUs for monitoring the lung function of preterm infants in the short and long term.
The primary objective is to measure homogeneity by Electrical Impedance Tomography (EIT) technology, used in the first weeks of life, for the development of BPD of grade 3, at 36 weeks postmenstrual age or death, in stable preterm infants requiring non-invasive ventilation. The secondary objective are to score if homogeneity at EIT are present and whether if they are associated with BPD. to ompare the distribution of regional lung ventilation obtained by EIT with the validated LUS scores.
详细描述
104 preterm infants born between 26 and 32 weeks of gestational age and/or with a birth weight < 1500g (very low birth weight infants - VLBW) with respiratory distress syndrome (RDS). are enrolled in the study In non-invasive ventilation (nasal continuous positive airway pressure -nCPAP- or high flow nasal -HFNC-) at 72h of life.
The study will be conducted at the Neonatal Intensive Care Unit of the Fondazione Policlinico San Matteo IRCSS,Pavia, Italy; PI Dr. S. Ghirardello; Chief of NICU.. Participation at the study will not modify the standard clinical care. In particular, the data obtained from this study will not be used to change the clinical practice in use at the time of the study and the investigators will supervise the proper conduct of the research.Recruitment of patients will be consecutive and continuous through the project investigator in daily clinical practice, if the criteria for inclusion in the study will be met and after obtaining informed consent from the parents.
The study procedures follow the standard clinical practice at our Unit, inclusive of lung ultrasound (LUS). In addition, Electrical Impedance Tomography (EIT) will be performed.
Briefly, after stabilization in delivery room, the clinicians start nCPAP or HFNC and administer surfactant therapy, according to "European guidelines 2022" and standardized internal protocols. The surfactant therapy should be given early in the course of the disease. The suggested protocol would be to treat worsening babies with RDS when FiO2 > 0.30 on CPAP pressure ≥6 cm H2O or if lung ultrasound suggests surfactant need. Less invasive surfactant administration (LISA) is the current preferred method of surfactant administration for spontaneously breathing babies on CPAP. The decision to intubate and start endotracheal mechanical ventilation (MV) is based on the development of respiratory acidosis (pH < 7.20, pCO2 > 60-65mmHg) or severe apnea. While on MV, the SatO2 target was 90%-94%; pH is kept between 7.25 and 7.35, and pCO2 is maintained between 45 and 60mmHg as per local protocols. Infants will be extubated if mean airway pressure (MAP) < 8 cmH20, FiO2 < 0.30, and good respiratory drive is evident.
EIT ENLIGHT 2100 (Timpel®) is a bedside system that uses high-frequency, low-intensity electric signals to provide live images of the breathing lung showing pulmonary performance in real-time. The specific neonatal 16-electrode bands made of hypoallergenic material, soft and thin, will be applied to the chest at the nipple level and will be connected to the tomograph for 60 minutes. During each intervention period, four 10-minute EIT sequences are recorded and for each recording, the first 30 stable consecutive breaths of artefact-free tidal ventilation will be identified. EIT recordings will be made after allowing the infant to stabilize, and in supine position. The raw EIT data will be reconstructed according to standardized guidelines with an anatomically correct and customized human chest algorithm using the manufacturer's software package to exclude impedance variations outside the boundaries of the left and right lungs. Once reconstructed, each of the recordings will be manually examined. Functional EIT images of the current volume distribution will be created, and data extracted from the entire lung, the right and left lungs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 26 Weeks 至 32 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants born between 26 and 32 weeks of gestational age and/or with a birth weight < 1500g (very low birth weight infants - VLBW) with respiratory distress syndrome (RDS).
排除标准
- •outborn infants
- •complex congenital malformations
- •metabolic, chromosomal, or other genetic abnormalities
- •pulmonary hypoplasia, congenital anomalies of surfactant proteins or other pulmonary abnormalities
- •any skin anomalies
- •need for mechanical ventilation > 72h after birth
- •any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
- •lack of parent consent.
结局指标
主要结局
The prognostic value of homogeneity of ventilation assessed with EIT
时间窗: 24 months
The primary objective is to measure the benefit of an earlier detection of the risk to develop BPD at 36 weeks postmenstrual age in stable preterm infants requiring non-invasive, in the first weeks of life, scoring the homogeneity of ventilation using EIT technology ventilatio measured by EIT technology, used in the first weeks of life, for the development of BPD at 36 weeks postmenstrual age
次要结局
- changes in homogeneity at EIT(24 months)
- homogeneity at EIT are associated with BPD or death(24 months)
- EIT and LUS score(24 months)
研究者
Stefano Ghirardello
MD, Chief of Neonatal Unit and Neonatal Intensive care Unit
Fondazione IRCCS Policlinico San Matteo di Pavia
