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到36周之间的“晚期早产儿” 新生儿并发症可以忽略不计，但长期前景与足月出生的新生儿基本相同(在 37周或更晚)。现在人们认识到，晚期早产儿死亡和严重早产儿的风险增加。 年新生儿呼吸道疾病，包括呼吸窘迫综合征和支气管肺发育不良 此外还有其他不良后果。由于四分之三的早产发生在早产晚期，这是 这是一个重大的公共卫生问题。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，在该试验中，女性有晚期早产的风险 早产随机接受倍他米松治疗，这是一种改善新生儿的标准护理方法 妊娠早期的呼吸系统和其他结局，或安慰剂。阿尔卑斯山试验显示， 新生儿呼吸道发病率。这些显著的发现将改变产科的实践，并理解 这种疗法的长期影响是最重要的。此外，关于长期肺病的信息很少 早产晚期出生的孩子的结局被公布，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至关重要 以及提供关于晚产早产儿童后遗症的迫切需要的信息。 这项题为“产前随机试验后出生队列中的肺部并发症”的申请 皮质类固醇：阿尔卑斯山后续研究“(阿尔卑斯-FS)描述了阿尔卑斯山试验的前瞻性随访 检验以下假设：1)接触倍他米松的儿童慢性肺部疾病发生率较低 与安慰剂相比，儿童慢性肺病因分娩时胎龄的不同而不同，从34岁到40岁不等 3)各种产科疾病，如先兆子痫和生长受限是 儿童慢性肺病，出生时占胎龄后。孩子们的母亲是 参加阿尔卑斯山的学生除了对呼吸功能进行全面评估外，还将进行肺功能测试。 通过问卷调查和病历记录了解病情。未来的呼吸道症状将通过以下方式确定 短信服务期限为一年。同时参加MFMU试验的低风险妇女所生子女 将作为期限控制。

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.