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

项目摘要/摘要 在过去，医学原则认为早产儿出生在34岁之间的“晚期早产儿”。 36周的新生儿并发症可以忽略不计，有长期的前景，主要是 与足月(37周或以上)出生的婴儿相同。现在人们认识到，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 窘迫综合征和支气管肺发育不良，以及其他不良后果。 由于四分之三的早产发生在早产晚期，这是一个重要的公众群体。 健康问题。为了解决这个问题，NICHD母婴医学部(MFMU) Network最近完成了产前晚期早产类固醇(ALPS)试验，妇女在该试验中 晚期早产的风险被随机分配给倍他米松，这是一种标准的 早孕时改善新生儿呼吸和其他结局的护理，或安慰剂。这个 阿尔卑斯试验显示，新生儿呼吸系统发病率显著下降。值得注意的是 这些发现将改变产科的实践，并理解这一发现的长期影响 治疗是最重要的。此外，关于儿童长期肺部结局的信息很少 早产儿出生在早产期晚期，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。 这份题为《随机后出生队列中的肺部并发症》的申请 产前皮质类固醇试验：阿尔卑斯山随访研究“(ALPS-FS)描述了一种 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，服用倍他米松的儿童患肺部疾病的几率更低。 慢性肺部疾病因出生时胎龄的不同而不同，从34到40周不等，以及3)不同的 产科疾病，如先兆子痫和生长受限是儿童的危险因素 慢性肺病，占出生时胎龄的比例。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。

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.