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

项目概要/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周的新生儿并发症可以忽略不计， 与足月（37周或更晚）出生的婴儿相同。现在人们认识到，晚期早产儿 死亡和新生儿严重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后期，这是一个重大的公众问题。 健康问题。为了解决这一问题，NICHD母胎医学单位（MFMU） 网络最近完成了产前晚期早产类固醇（ALPS）试验， 晚期早产的风险被随机分配到betternet，一种标准的治疗方法， 改善早期妊娠新生儿呼吸和其他结局的护理，或安慰剂。的 ALPS试验显示新生儿呼吸道疾病发病率显著降低。这些显著 研究结果将改变产科的实践，并了解其长期影响。 治疗是最重要的此外，关于儿童长期肺部结局的信息很少， 早产晚期出生的婴儿数量已公布，但没有关于产前检查影响的统计数据 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“肺部并发症的出生队列后，随机 肾上腺皮质类固醇试验：ALPS随访研究”（ALPS-FS）描述了一项 ALPS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beta3的患者的肺部疾病较低，2）儿童期 慢性肺部疾病因分娩时胎龄而异，从34周到40周，以及3）各种 产科条件，如先兆子痫和生长受限是儿童的危险因素 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。 在同期MFMU试验中登记的低风险妇女所生的孩子将作为长期对照。

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.