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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：
10268177
负责人：
Cynthia T McEvoy
金额：
$ 67.35万
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/10268177
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.

项目摘要早产发生在10%的所有出生在美国，是最常见的原因受损的肺生长和发育，肺功能下降，呼吸系统发病率增加，医疗保健增加整个童年的费用。目前还没有已知的疗法来刺激肺生长，改善肺功能，肺功能，并降低早产后呼吸道疾病的发病率。连续阳性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，降低新生儿重症监护室（NICU）中支气管肺发育不良的发生率。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CPAP的最佳应用时间。对病情稳定的恢复期早产儿停止CPAP治疗。早期使用CPAP可能对早产儿肺有益，然而，我们的临床前和临床数据强烈表明，肺的机械拉伸可能刺激肺的生长和发育。这项随机单中心研究的主要目的是确定在NICU中对稳定早产儿进行额外2周的CPAP可增加肺泡肺与接受CPAP治疗的婴儿相比，6个月矫正年龄时的肺容量和肺弥散量按照标准治疗停止。当患者符合特定的已发表CPAP稳定性时，将对其进行随机化 CPAP停药标准。这项研究具有巨大的公共卫生意义，因为它有可能改变新生儿重症监护病房的呼吸护理标准，并尽量减少早产对肺部的不良影响促进经济增长和发展。