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：
10683051
负责人：
Cynthia T McEvoy
金额：
$ 64.39万
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/10683051
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 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 Productivity Public Health Publishing Randomized Randomized, Controlled Trials Reporting Research Steroids Stretching Therapeutic Time United States Volutrauma Wheezing animal data antenatal atelectrauma efficacy evaluation improved in utero intratracheal pressure lung development lung volume meetings nCPAP Ventilation novel pre-clinical premature primary outcome pulmonary function randomized trial randomized, clinical trials 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.

项目摘要早产发生在美国的所有出生中的10％，是肺部受损的最常见原因生长和发育，肺功能降低，呼吸道发病率增加并增加医疗保健整个童年的成本。目前尚无刺激肺部生长的已知疗法，改善早产后肺功能，并降低呼吸道发病率。连续阳性的应用早产后气道压力（CPAP）是稳定和维持肺部体积的护理标准，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速度。尽管对CPAP的早期应用已经进行了充分的研究，但几乎没有证据表明最佳时间稳定康复的早产儿中停止CPAP。早期使用CPAP可能会使早产肺受益最小化伤害；但是，我们的临床前和临床数据强烈表明肺的机械拉伸来自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是确定在NICU中为稳定的早产儿再增加2周的CPAP会增加肺泡肺与患有CPAP的婴儿相比按照标准护理停产。当患者履行特定已发布的CPAP稳定性时，他们将被随机化 CPAP中断的标准。这项研究具有更改的潜力，具有极大的公共卫生意义 NICU中呼吸护理的标准，并最大程度地减少肺部早产的不良影响增长与发展。