Pulmonary Complications in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids: the ALPS Follow-Up Study - Data Coordinating Center (ALPS FS - DCC)

产前皮质类固醇随机试验后出生队列的肺部并发症：ALPS 随访研究 - 数据协调中心 (ALPS FS - DCC)

• 批准号: 9177307
• 负责人: Kathleen Ann Jablonski
• 金额: $ 190.38万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-05 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9177307
• 关键词: Accounting; Address; Adrenal Cortex Hormones; Adult; Age; Asthma; Betamethasone; Birth; Breathing; Bronchiectasis; Bronchopulmonary Dysplasia; Cessation of life; Child; Childhood; Chronic; Chronic lung disease; Confidential Information; Data; Data Coordinating Center; Development; Diagnosis; Discipline of obstetrics; Elderly; Enrollment; Exposure to; Fetal Growth Retardation; Fetal Lung; Gestational Age; Growth; Healthcare; Hospitalization; Incidence; Infant; Lead; Lung; Lung diseases; Maternal-Fetal Medicine Units Network; Medical; Medical Records; Morbidity - disease rate; Mothers; National Institute of Child Health and Human Development; Neonatal; Neonatal respiratory morbidity; Newborn Infant; Obstructive Lung Diseases; Outcome; Oxygen; Parents; Participant; Pharmaceutical Preparations; Placebos; Population; Pre-Eclampsia; Pregnancy; Pregnant Women; Premature Birth; Premature Infant; Prevalence; Primary Prevention; Public Health; Publishing; Pulmonary function tests; Questionnaires; Randomized; Randomized Controlled Trials; Respiratory Signs and Symptoms; Risk; Risk Factors; School-Age Population; Spirometry; Steroids; Testing; Text; Trial of Labor; Vascular resistance; Woman; abstracting; adverse outcome; aged; cohort; fetal medicine; follow-up; improved; interest; intraamniotic infection; neonatal care; offspring; parent grant; premature; primary outcome; prospective; randomized trial; respiratory; respiratory distress syndrome; respiratory health; school health; secondary outcome; standard of care; statistics; surfactant; symptomatology

Project Summary/Abstract In the past, medical tenets held that premature infants born “late preterm” between 34 and 36 weeks have negligible neonatal complications with long term prospects essentially the same as those born at term (at 37 weeks or later). It is now recognized that late preterm infants are at increased risk for death and serious neonatal respiratory morbidity including respiratory distress syndrome and bronchopulmonary dysplasia, in addition to other adverse outcomes. Since three fourths of preterm births occur in the late preterm period, this is a significant public health problem. To address this issue, the NICHD Maternal-Fetal Medicine Units (MFMU) Network recently completed the Antenatal Late Preterm Steroids (ALPS) trial where women at risk for late preterm delivery were randomized to betamethasone, a therapy that is standard of care for improving neonatal respiratory and other outcome at earlier gestations, or placebo. The ALPS trial showed a significant decrease in neonatal respiratory morbidity. These notable findings will change practice in obstetrics, and understanding the long-term implications of this therapy is paramount. Moreover, little information on long-term pulmonary outcomes of children born in the late preterm period are published, and no statistics on the effects of antenatal betamathasone exposure in this population exists. These data are critical to understand the results of ALPS as well as to provide much needed information regarding childhood sequelae of late preterm birth. This application entitled “Pulmonary Complications in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids: the ALPS Follow-Up Study” (ALPS-FS) describes a prospective follow-up of the ALPS trial to test the following hypotheses: 1) childhood chronic lung disease is lower in those exposed to betamethasone compared with placebo, 2) childhood chronic lung disease varies by gestational age at delivery from 34 to 40 weeks, and 3) various obstetric conditions such as preeclampsia and growth restriction are risk factors for childhood chronic lung disease, after accounting for gestational age at birth. Children whose mothers were enrolled in ALPS will have pulmonary function testing in addition to a comprehensive assessment of respiratory illness via questionnaire and medical records. Prospective respiratory symptomatology will be ascertained via text messaging for a period of one year. Children born to low risk women enrolled in a concurrent MFMU trial will serve as term controls

项目摘要/摘要 在过去，医学原则认为早产儿出生的年龄在34到36岁之间。 几周的新生儿并发症可以忽略不计，长期前景基本相同。 与足月(37周或更晚)出生的人一样。现在人们认识到，晚期早产儿在 死亡风险增加和包括呼吸窘迫在内的严重新生儿呼吸道疾病 综合征和支气管肺发育不良，以及其他不良后果。从三点开始 四分之三的早产发生在早产晚期，这是一个重大的公共卫生问题。 有问题。为了解决这一问题，NICHD母婴医学部(MFMU)网络 最近完成了产前晚期早产类固醇(ALPS)试验，在该试验中，女性有患上 晚期早产被随机分成倍他米松，这是一种标准的治疗方法 改善早孕新生儿呼吸和其他结局，或安慰剂。阿尔卑斯山 试验表明，新生儿呼吸道发病率显著下降。这些值得注意的发现将 改变产科的实践，了解这种疗法的长期影响是 派拉蒙。此外，关于出生在中国的儿童的长期肺部结局的信息很少 公布了早产晚期，但没有关于产前影响的统计数据 该人群中存在倍他米松暴露。这些数据对于理解 阿尔卑斯山的结果，以及提供急需的关于儿童后遗症的信息 晚产早产。 这项名为“出生队列中的肺部并发症”的随机试验 《产前皮质类固醇：阿尔卑斯山随访研究》(ALPS-FS)描述了一种 阿尔卑斯山试验的后续行动，以检验以下假设：1)儿童慢性肺病 与安慰剂相比，暴露于倍他米松的患者更低，2)儿童慢性肺病 疾病因分娩时的胎龄不同而不同，从34到40周不等，以及3)各种产科疾病 先兆子痫和生长受限等情况是儿童慢性疾病的危险因素 肺部疾病，占出生时的胎龄。孩子们的母亲是 注册阿尔卑斯山除了进行全面的肺功能测试外，还将进行肺功能测试 通过问卷调查和病历记录评估呼吸系统疾病。预期 呼吸道症状将通过短信确认，为期一年。 同时参加MFMU试验的低风险妇女所生的孩子将作为足月对照