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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：
10026341
负责人：
Cynthia T McEvoy
金额：
$ 67.47万
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/10026341
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 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 Respiratory distress Respiratory physiology 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 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.

项目摘要在美国，10%的新生儿发生早产，这是导致肺损伤的最常见原因生长发育，肺功能下降，呼吸道发病率增加，医疗保健增加整个童年的花费。目前还没有已知的疗法来刺激肺生长，改善改善肺功能，减少早产后呼吸道疾病的发病率。连续正数的应用早产后早期的呼吸道压力(CPAP)是稳定和维持肺容量的护理标准，避免插管，降低新生儿重症监护病房(NICU)的支气管肺发育不良发生率。虽然CPAP的早期应用已经得到了很好的研究，但很少有证据确定最佳的应用时间稳定恢复期早产儿停用CPAP。早期使用CPAP可能通过以下方式使早产儿肺受益最大限度地减少损伤；然而，我们的临床前和临床数据强烈表明，机械拉伸肺 CPAP可能会刺激肺的生长发育。这项随机单中心研究的主要目的是确定在NICU为稳定的早产儿增加两周的CPAP可增加肺泡校正年龄6个月的婴儿与接受CPAP的婴儿的容量和肺弥散能力的比较根据标准护理停止使用。当患者达到特定公布的CPAP稳定性时，他们将被随机分组终止CPAP的标准。这项研究具有重大的公共卫生意义，因为它有可能发生变化提高NICU的呼吸护理标准，最大限度地减少早产对肺部的不良影响成长和发展。