Randomized Trial of Antenatal Late Preterm Steroids (ALPS) - Clinical Coordinatin

产前晚期早产类固醇 (ALPS) 的随机试验 - 临床协调

基本信息

批准号：
8120579
负责人：
CYNTHIA GYAMFI-BANNERMAN
金额：
$ 8.19万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
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 2013-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8120579
关键词：
Accounting Address Admission activity Adrenal Cortex Hormones Age Algorithms Apnea Betamethasone Biometry Birth Bronchopulmonary Dysplasia Budgets Cannulas Caring Cessation of life Child Child health care Chronic lung disease Clinical Clinical Trials Companions Consensus Consent Continuous Positive Airway Pressure DNA Data Coordinating Center Discipline of obstetrics Dose Educational workshop Effectiveness Epithelial Fetal Lung Future Gestational Age Glucocorticoid Receptor Healthcare Systems Hospitalization Hospitals Hour Human Development Hyperbilirubinemia Icterus Infant Institutes Intramuscular Injections Letters Life Masks Mechanical Ventilators Membrane Mission Morbidity - disease rate National Heart, Lung, and Blood Institute National Institute of Child Health and Human Development Necrotizing Enterocolitis Neonatal Neonatal Intensive Care Units Newborn Infant Nose Nurseries Outcome Oxygen Perinatology Placebos Polymorphism Analysis Population Pregnancy Pregnant Women Premature Birth Premature Infant Premature Labor Procedures Production Provider Public Health Randomized Recommendation Research Design Research Methodology Respiratory distress Respiratory physiology Risk Role Rupture Sampling Schedule Scientist Sepsis Sodium Channel Steroids Translating United States National Institutes of Health Universities Washington Woman beta-2 Adrenergic Receptors cost design economic impact epithelial Na+ channel fetal medicine health economics improved intraventricular hemorrhage lung development mortality natural hypothermia neonatal death neonate premature primary outcome programs public health relevance randomized trial receptor respiratory respiratory distress syndrome stillbirth surfactant symposium

项目摘要

DESCRIPTION (provided by applicant): The use of antenatal steroids to accelerate fetal lung development and induce endogenous surfactant production is perhaps one of the most important advances in the field of obstetrics to improve the outcome of the very premature neonate. The recommendation of the 1994 NIH Consensus Conference was that all pregnant women between 24 and 33 completed weeks of gestation who are at risk of preterm delivery within 7 days should be considered candidates for antenatal treatment with a single course of corticosteroids. However the very premature infant accounts for a relatively small portion of preterm birth. Over 9% of all births in 2005 were between 34 and 36 completed weeks with a third of those estimated to have some form of respiratory morbidity. In 2005, at a National Institute of Child Health and Human Development (NICHD) workshop to address this emerging issue, one of the recommendations made to improve outcomes was to investigate the use of antenatal corticosteroids in this "late preterm" population. This study is a collaborative effort of the NICHD MFMU Network, which consists of fourteen academic clinical centers, a data coordinating center, and the Pregnancy and Perinatology Branch of the NICHD. The proposed study design is a randomized, double-masked, clinical trial of 2800 women with a singleton pregnancy who are between 34 weeks 0 days and 36 weeks 5 days with spontaneous preterm labor or ruptured membranes, or whose care providers have scheduled delivery to take place in the next 7 days, and no later than 36 weeks 6 days. Women with prior corticosteroid use during pregnancy, and those whose delivery is expected within 6 hours will be excluded. Gestational age is determined by a standardized algorithm prior to randomization. Eligible and consenting women will be randomized to a course of two intramuscular injections containing 12 mg of betamethasone, 24 hours apart or to a similar course of an identically appearing placebo. The first dose will be administered immediately after randomization. All women will be followed until hospital discharge following delivery and neonates until discharge or 120 days of age, whichever is sooner. The composite primary outcome is stillbirth or neonatal death before 24 hours or the need for neonatal respiratory support within the first 72 hours of life. Respiratory support is defined as the use of continuous positive airway pressure or humidified high-flow nasal cannula for at least two continuous hours, oxygen requirement of FiO2 e 0.3 for at least four continuous hours, or mechanical ventilator use. The use of ECMO is also included in the primary outcome. In summary, antenatal corticosteroids could potentially reduce respiratory morbidity in newborn infants born in the late preterm period, which in turn could translate into a lasting improvement in the health of children, and a reduction in burden on the health care system. PUBLIC HEALTH RELEVANCE: The increase in the rate of preterm birth over the past 10 years has been driven in part by the increase in late preterm births, defined as those births occurring between 34 and 36 weeks. Late preterm infants are more likely to suffer complications such as respiratory distress, hypothermia, and jaundice and are readmitted to the hospital more frequently than infants born at term. The use of antenatal corticosteroids has been shown to improve lung function in very premature infants, but has not been evaluated in those likely to deliver in the late preterm period. If shown to reduce the need for respiratory support and thus to decrease the rate of special care nursery admissions and improve short-term outcomes, the public health and economic impact will be considerable.

描述（由申请人提供）：使用产前类固醇加速胎儿肺发育并诱导内源性表面活性剂的产生，这可能是妇产科领域最重要的进步之一，以改善过早的新生儿的结果。 1994年NIH共识会议的建议是，所有在7天内有早产的妊娠24至33周之间的孕妇应被视为候选候选候选固定固醇的产前治疗的候选者。但是，早产的婴儿是早产相对较小的部分。 2005年，超过9％的出生时间介于34至36个完整的几周之间，其中三分之一估计具有某种形式的呼吸道发病率。 2005年，在美国国家儿童健康与人类发展研究所（NICHD）讲习班以解决这一新出现的问题，为改善预后的建议之一是调查在这个“晚期”人群中使用产前皮质类固醇的使用。这项研究是NICHD MFMU网络的一项合作努力，该网络由14个学术临床中心，一个数据协调中心以及NICHD的怀孕和围产科分支组成。拟议的研究设计是一项随机，双掩盖的临床试验，对2800名单身妊娠的女性进行了34周0天到36周之间的5天，自发早产或膜破裂，或者他们的护理提供者计划在接下来的7天内进行递送，而不晚于36周，而无需晚些时候6天。怀孕期间先前使用皮质类固醇的妇女，以及预计在6小时内分娩的妇女将被排除。胎龄在随机化之前由标准化算法确定。符合条件和同意的妇女将被随机分为两种肌肉内注射，其中包含12毫克β-塞米松，相距24小时或相似的同样出现的安慰剂。第一个剂量将在随机分组后立即给予。所有妇女将被遵循，直到分娩后出院和新生儿出院，直到出院或120天大，以较早者为准。复合材料的主要结果是24小时前死亡或新生儿死亡，或者在生命的前72小时内需要新生儿呼吸道支持。呼吸支持定义为使用连续的正气道压力或加湿的高流量鼻套管至少连续两个小时，氧气需求至少连续四个连续四个小时或使用机械呼吸机。 ECMO的使用也包括在主要结果中。总而言之，产前皮质类固醇可能有可能减少早产时期出生的新生婴儿的呼吸道发病率，进而可以转化为儿童健康状况的持久改善，并减轻医疗保健系统负担的负担。公共卫生相关性：过去10年来早产率的提高部分是由于早产晚期出生的增加而定为34周到36周之间的出生。早产儿更可能患有呼吸窘迫，体温过低和黄疸等并发症，并且比学期出生的婴儿更频繁地进入医院。已经证明，产前皮质类固醇的使用可以改善非常过早的婴儿的肺功能，但在早产期后期可能递送的人中尚未评估。如果显示出减少呼吸支持的需求，从而降低特殊护理托儿所的入院率并改善短期结局，那么公共卫生和经济影响将是相当大的。