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: 9551693
• 负责人: Kathleen Ann Jablonski
• 金额: $ 190.34万
• 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/9551693
• 关键词: Accounting; Address; Adrenal Cortex Hormones; Adult; Age; Asthma; Betamethasone; Birth; 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; Inhalation; Longterm Follow-up; 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; Standardization; Steroids; Testing; Text Messaging; Trial of Labor; Vascular resistance; Woman; adverse outcome; aged; antenatal; cohort; follow-up; improved; interest; intraamniotic infection; mortality risk; offspring; parent grant; premature; primary outcome; prospective; randomized trial; recruit; 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

项目总结/文摘