TRIAL OF LATE SURFACTANT TO PREVENT BRONCHOPULMONARY

晚期表面活性剂预防支气管肺损伤的试验

• 批准号: 8356693
• 负责人: ERIC EICHENWALD
• 金额: $ 0.42万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356693
• 关键词: Adrenal Cortex Hormones; Age; Birth; Bronchodilator Agents; Bronchopulmonary Dysplasia; Caffeine; Clinical Data; Clinical Research; Clinical Trials; Diuretics; Extremely Low Birth Weight Infant; Funding; Genetic; Grant; Incidence; Infant; Inflammation; Injury; Late Effects; Lung; Lung diseases; Mechanical ventilation; Monitor; Morbidity - disease rate; National Center for Research Resources; Necrotizing Enterocolitis; Neonatal; Outcome; Patent Ductus Arteriosus; Pathogenesis; Periventricular Leukomalacia; Premature Infant; Prevalence; Prevention approach; Principal Investigator; Research; Research Infrastructure; Resources; Retinopathy of Prematurity; Safety; Severities; Source; Therapeutic; Toxic effect; United States; United States National Institutes of Health; Vitamin A; cost; inhaled nitric oxide; intraventricular hemorrhage; oxygen toxicity; postnatal; premature; prevent; respiratory; surfactant

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT Bronchopulmonary dysplasia (BPD) of prematurity has emerged as the most common, lethal and expensive neonatal pulmonary disorder in the United States. The pathogenesis of BPD is multi-factorial, has a genetic contribution, and involves injury and inflammation associated with oxygen toxicity and mechanical ventilation in an underdeveloped, immature lung. The estimated prevalence is 30,000 cases/year. Current therapeutic approaches to the prevention and treatment of lung disease in premature infants, including antenatal corticosteroid treatment, replacement surfactant at birth, postnatal administration of corticosteroids, vitamin A, diuretics, caffeine, and bronchodilators have not significantly impacted the overall occurrence of BPD. Recent clinical trials of inhaled nitric oxide (iNO) indicate a beneficial impact on the incidence and severity of BPD as well as short- and long-term safety including 2-year neurodevelopmental outcome. Extremely low birth weight infants (ELBW, defined as 1 week of age. Aim 2. Assess effects of late surfactant treatment on the respiratory status of ventilated ELBW infants. We will collect clinical data to investigate effects of surfactant treatment on both short-term respiratory support need, as assessed by the Respiratory Severity Score (RSS), and pulmonary status at 36 weeks PMA (survival without BPD). We also will monitor for evidence of toxicity as indicated by any of the known complications of surfactant administration as well as by the occurrence and severity of other common morbidities of preterm infants, including intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL), patent ductus arteriosus (PDA), necrotizing enterocolitis (NEC) and retinopathy of prematurity (ROP). We expect that combined iNO-surfactant therapy will be safe. We will determine the relationship between surfactant function (Aim 1) and both short-term respiratory status and 36-week outcome.

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 子项目的主要研究者可能是由其他来源提供的， 包括其他NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 摘要 在美国，早产儿支气管肺发育不良（BPD）已成为最常见、最致命和最昂贵的新生儿肺部疾病。BPD的发病机制是多因素的，具有遗传贡献，并且涉及与氧毒性和未发育成熟的肺中的机械通气相关的损伤和炎症。 估计流行率为30 000例/年。目前预防和治疗早产儿肺部疾病的治疗方法，包括产前皮质类固醇治疗、出生时表面活性物质替代、出生后皮质类固醇、维生素A、利尿剂、咖啡因和支气管扩张剂给药，对BPD的总体发生率没有显著影响。 最近的吸入一氧化氮（iNO）临床试验表明，吸入一氧化氮（iNO）对BPD的发生率和严重程度以及短期和长期安全性（包括2年神经发育结果）具有有益影响。 极低出生体重儿（ELBW），定义为1周龄。 目标2.评估晚期表面活性物质治疗对通气ELBW婴儿呼吸状态的影响。 我们将收集临床数据，以研究表面活性剂治疗对短期呼吸支持需求（通过呼吸严重程度评分（RSS）评估）和36周PMA时的肺状态（无BPD的生存期）的影响。我们还将监测毒性证据，如表面活性剂给药的任何已知并发症以及早产儿其他常见疾病的发生率和严重程度，包括脑室内出血（IVH）和脑室周围白质软化症（PVL）、动脉导管未闭（PDA）、坏死性小肠结肠炎（NEC）和早产儿视网膜病变（ROP）。 我们预期iNO-表面活性剂联合治疗是安全的。 我们将确定表面活性物质功能（目标1）与短期呼吸状态和36周结局之间的关系。