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)

基本信息

批准号：
10511115
负责人：
CYNTHIA GYAMFI-BANNERMAN
金额：
$ 16.57万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-08-05 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10511115
关键词：
Pulmonary Complications Birth Cohort after

项目摘要

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至36周之间出生的“早产晚期” 具有长期前景的新生儿并发症可忽略不计的，与期限出生的并发症基本相同（在 37周或更晚）。现在已经认识到，早产儿的死亡风险增加和严重新生儿呼吸道发病率，包括呼吸窘迫综合征和支气管肺发育不良，增加其他不利结果。由于早产时期的四分之三的早产时间是一个重大的公共卫生问题。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早产类固醇（ALPS）试验，该试验有迟到的妇女早产交付被随机分配给倍替米松，这种疗法是改善新生儿的护理标准早期妊娠或安慰剂时的呼吸和其他结果。阿尔卑斯山试验显示明显下降新生儿呼吸道发病率。这些值得注意的发现将改变产科的实践，并了解这种疗法的长期影响至关重要。此外，关于长期肺的信息很少在早产期晚期出生的孩子的结果已发表，没有关于天线影响的统计数据存在该人群中的betamathasone暴露。这些数据对于理解阿尔卑斯山的结果至关重要以及提供有关早产晚期后遗症的急需信息。该应用标题为“产前试验后出生队列中的肺并发症皮质类固醇：阿尔卑斯山的随访研究”（ALPS-FS）描述了对阿尔卑斯山试验的前瞻性随访测试以下假设：1）暴露于β-塞米松的儿童慢性肺部疾病较低与安慰剂相比，2）胎龄从34到40 几周和3）各种产科条件，例如先兆子痫和增长限制是风险因素儿童慢性肺部疾病，考虑到出生时的胎龄。母亲的孩子除了全面评估呼吸外，还将参加阿尔卑斯山的肺功能测试通过问卷和病历的疾病。前瞻性呼吸症状学将通过文字消息传递一年。受到同一MFMU试验的低风险妇女出生的孩子将用作术语控件。