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

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 - 临床协调中心 (ALPS-FS: CCC)

• 批准号: 9176913
• 负责人: CYNTHIA GYAMFI-BANNERMAN
• 金额: $ 17.52万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 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/9176913
• 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; Clinical; Confidential Information; Data; 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.

项目概要/摘要 过去，医学原则认为，34 岁之间出生的早产儿为“晚期早产”。 36 周的新生儿并发症可以忽略不计，长期前景基本上是 与足月出生的婴儿（37 周或以后）相同，现在已认识到晚期早产儿。 死亡和严重新生儿呼吸道疾病（包括呼吸道疾病）的风险增加 除了其他不良后果外，还有窘迫综合征和支气管肺发育不良。 由于四分之三的早产发生在早产晚期，因此这是一个重要的公众 为了解决这个问题，NICHD 母胎医学中心 (MFMU) Network 最近完成了产前晚期早产类固醇 (ALPS) 试验，其中妇女 晚期早产风险被随机分配至倍他米松，这是一种标准疗法 改善妊娠早期新生儿呼吸和其他结局的护理或安慰剂。 ALPS 试验显示新生儿呼吸道疾病发病率显着下降。 研究结果将改变产科实践，并了解这一结果的长期影响 此外，关于儿童长期肺部结局的信息很少。 早产晚期出生的人已发表，并没有关于产前影响的统计数据 这些数据对于了解该人群中存在的倍他松暴露情况至关重要。 ALPS 的结果以及提供有关儿童后遗症的急需信息 晚期早产。 该申请题为“随机分组后出生队列中的肺部并发症” 产前皮质类固醇试验：ALPS 随访研究”（ALPS-FS）描述了 对 ALPS 试验进行前瞻性随访，以检验以下假设：1）儿童慢性病 与安慰剂相比，接触倍他米松的患者肺部疾病发生率较低，2) 儿童期 慢性肺部疾病因分娩时的胎龄而异，从 34 周到 40 周不等，3) 各种 先兆子痫和生长受限等产科疾病是儿童期的危险因素 考虑到出生时的胎龄，患有慢性肺病。 加入 ALPS 后，除了全面的检查外，还将进行肺功能测试 通过问卷和前瞻性医疗记录评估呼吸系统疾病。 呼吸道症状将通过短信确定，为期一年。 参加同时 MFMU 试验的低风险女性所生的孩子将作为术语对照。