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: 9345580
• 负责人: Kathleen Ann Jablonski
• 金额: $ 190.56万
• 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 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9345580
• 关键词: Accounting; Address; Adrenal Cortex Hormones; Adult; Age; Asthma; Betamethasone; Birth; Breathing; Bronchiectasis; Bronchopulmonary Dysplasia; Caring; 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; Follow-Up Studies; Gestational Age; Growth; Healthcare; Hospitalization; Incidence; Infant; 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; Recruitment Activity; Respiratory Signs and Symptoms; Risk; Risk Factors; School-Age Population; Spirometry; Standardization; Steroids; Testing; Text; Trial of Labor; Vascular resistance; Woman; adverse outcome; aged; antenatal; autoimmune lymphoproliferative syndrome; cohort; follow-up; improved; interest; intraamniotic infection; offspring; parent grant; premature; primary outcome; prospective; randomized trial; respiratory; respiratory distress syndrome; respiratory 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

项目总结/摘要 在过去，医学原则认为，早产儿出生“晚早产”之间的34和36 新生儿并发症可忽略不计，长期前景基本相同 与足月出生（37周或更晚）的人一样。现在认识到，晚期早产儿在 增加死亡和新生儿呼吸系统严重疾病（包括呼吸窘迫）的风险 综合征和支气管肺发育不良，以及其他不良后果。自从三 四分之一的早产发生在早产后期，这是一个重大的公共卫生问题。 问题.为了解决这一问题，NICHD母胎医学单位网络 最近完成了产前晚期早产类固醇（ALPS）试验， 晚期早产被随机分配至倍他米松组，倍他米松是一种标准治疗， 改善早期妊娠的新生儿呼吸和其他结果，或安慰剂。阿尔卑斯山 试验表明，新生儿呼吸道疾病发病率显著下降。这些显著的发现将 改变产科实践，并了解这种疗法的长期影响， 至高无上。此外，几乎没有关于出生在美国的儿童的长期肺部结果的信息。 关于晚期早产的数据没有公布，也没有关于产前检查的影响的统计数据。 该人群中存在倍他米松暴露。这些数据对于了解 ALPS的结果，以及提供急需的有关儿童后遗症的信息， 晚期早产 这项申请题为“肺部并发症在出生队列后的随机试验， 脑皮质类固醇：ALPS随访研究”（ALPS-FS）描述了一项前瞻性研究， ALPS试验的随访，以检验以下假设：1）儿童慢性肺部疾病是 与安慰剂组相比，暴露于倍他米松的儿童的肺损伤率较低，2）儿童慢性肺损伤 疾病因分娩时的胎龄而异，从34周到40周，以及3）各种产科疾病 先兆子痫和生长受限等疾病是儿童慢性 肺部疾病，出生时占胎龄后。那些母亲 参加ALPS的患者除了全面的肺功能检查外， 通过问卷和医疗记录评估呼吸系统疾病。前瞻性 将通过短信确定呼吸系统疾病，为期一年。 入选同期MFMU试验的低风险女性所生的儿童将作为长期对照