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: 9345579
• 负责人: CYNTHIA GYAMFI-BANNERMAN
• 金额: $ 16.57万
• 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/9345579
• 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; Clinical; Confidential Information; Data; 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; 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.

项目摘要/摘要 过去，医疗宗旨认为早产婴儿在34岁之间出生的“早产晚期” 36周的新生儿并发症可忽略不计，长期前景基本上是 与学期出生的人相同（在37周或以后）。现在已经认识到早产婴儿 死亡的风险增加和严重的新生儿呼吸道发病率，包括呼吸系统 除其他不良结果外，遇险综合征和支气管肺发育不良。 由于早产时期三分之三的早产时间，这是一个重要的公众 健康问题。为了解决这个问题，NICHD孕产医学单位（MFMU） 网络最近完成了产前晚期早产类固醇（ALP）试验，妇女在 早产晚期递送的风险被随机分配给替他米松，这是一种标准的疗法 护理早期妊娠或安慰剂时改善新生儿呼吸道和其他结果。 阿尔卑斯山试验显示，新生儿呼吸道发病率显着降低。这些值得注意 调查结果将改变产科的实践，并理解这一点的长期影响 治疗至关重要。此外，关于儿童长期肺癌结局的信息很少 出生于早产时期，没有关于天线影响的统计数据 存在该人群中的betamathasone暴露。这些数据对于了解 阿尔卑斯山的结果以及提供有关儿童后遗症的急需信息 早产晚期。 该应用名为“随机后出生队列中的肺并发症 产前皮质类固醇的试验：阿尔卑斯山随访研究（ALPS-FS）描述了 阿尔卑斯山试验的前瞻性随访，以检验以下假设：1）儿童慢性 与安慰剂相比，暴露于倍他塞米松的患者中的肺病较低，2）童年 慢性肺病随胎龄从34周到40周而变化，3） 子痫前期和增长限制等产科条件是儿童期的危险因素 慢性肺部疾病，在出生时考虑胎龄之后。母亲的孩子 除了综合外，参加阿尔卑斯山还将进行肺功能测试 通过问卷和病历评估呼吸道疾病。预期 呼吸道症状学将通过文本消息传递确定一年。 接受MFMU试验的低风险妇女出生的孩子将作为期限控制。