Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function: A Randomized Controlled Trial

延长稳定早产儿的 CPAP 治疗以促进肺部生长和功能：一项随机对照试验

基本信息

批准号：
10480783
负责人：
Cynthia T McEvoy
金额：
$ 67.28万
依托单位：
OREGON HEALTH & SCIENCE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-28 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10480783
关键词：
Abbreviations Acute Address Adult Adverse effects Adverse event Age Age-Months Alveolar Asthma Birth Bronchopulmonary Dysplasia Caring Child Childhood Clinical Clinical Data Clinical Investigator Collaborations Congenital diaphragmatic hernia Continuous Positive Airway Pressure Data Diffuse Diffusion Ferrets Functional Residual Capacity Future Gestational Age Growth Growth and Development function Health Care Costs Impairment Infant Infant respiratory distress Injury Intubation Lung Measurement Measures Mechanical ventilation Mechanics Modeling Neonatal Intensive Care Units Neonatology Outcome Patients Physiological Physiology Premature Birth Premature Infant Public Health Publishing Randomized Randomized Clinical Trials Randomized Controlled Trials Reporting Research Steroids Stretching Therapeutic Time United States Volutrauma Wheezing animal data antenatal atelectrauma improved in utero intratracheal pressure lung development lung volume meetings nCPAP Ventilation novel pre-clinical premature primary outcome pulmonary function randomized trial respiratory respiratory health respiratory morbidity secondary outcome standard care standard of care surfactant treatment as usual

项目摘要

Project Summary Preterm delivery occurs in 10% of all births in the United States and is the most common cause of impaired lung growth and development, decreased lung function, increased respiratory morbidity, and increased health care costs throughout childhood. There are currently no known therapies to stimulate lung growth, improve lung function, and decrease respiratory morbidity after preterm birth. The application of continuous positive airway pressure (CPAP) early after a preterm birth is the standard of care to stabilize and maintain lung volumes, avoid intubation, and decrease rates of bronchopulmonary dysplasia in the neonatal intensive care unit (NICU). Although early application of CPAP has been well studied, there is little evidence defining the optimal time to discontinue CPAP in stable convalescing preterm infants. Early use of CPAP may benefit the preterm lung by minimizing injury; however, our preclinical and clinical data strongly suggest that mechanical stretch of the lung from CPAP may stimulate lung growth and development. The primary aim of this randomized single center study is to establish that 2 additional weeks of CPAP in the NICU for stable preterm infants increases alveolar lung volume and lung diffusing capacity at 6 months of corrected age compared to infants who had CPAP discontinued as per standard care. Patients will be randomized when they fulfill specific published CPAP stability criteria for CPAP discontinuation. This research has great public health significance for its potential to change the standard of respiratory care in the NICU, and minimize the adverse effects of premature birth upon lung growth and development.

项目概要在美国，早产占所有新生儿的 10%，是肺部受损的最常见原因生长和发育、肺功能下降、呼吸道疾病发病率增加以及医疗保健增加整个童年的费用。目前尚无已知的疗法可以刺激肺部生长、改善肺功能，并降低早产后呼吸系统的发病率。持续积极的应用早产后早期的气道压力（CPAP）是稳定和维持肺容量的护理标准，避免插管，并降低新生儿重症监护病房 (NICU) 中支气管肺发育不良的发生率。尽管 CPAP 的早期应用已得到充分研究，但几乎没有证据确定最佳的治疗时间。对于稳定恢复期的早产儿，停止 CPAP 治疗。早期使用 CPAP 可能对早产儿肺部有益：最大限度地减少伤害；然而，我们的临床前和临床数据强烈表明，肺的机械拉伸 CPAP 可能会刺激肺部生长和发育。这项随机单中心研究的主要目的目的是确定对于稳定的早产儿，在新生儿重症监护病房 (NICU) 中额外进行 2 周的 CPAP 治疗可增加肺泡肺功能与接受 CPAP 治疗的婴儿相比，校正年龄 6 个月时的肺容量和肺弥散能力按照标准护理停止。当患者达到特定公布的 CPAP 稳定性时，将对其进行随机分组 CPAP 停止的标准。这项研究因其潜在的改变而具有重大的公共卫生意义提高NICU呼吸护理水平，最大限度减少早产对肺部的不利影响成长和发展。