Randomized Trial of Antenatal Late Preterm Steroids (ALPS) - DCC

产前晚期早产类固醇 (ALPS) 的随机试验 - DCC

• 批准号: 8306818
• 负责人: ELIZABETH ANN THOM
• 金额: $ 46.65万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-05 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8306818
• 关键词: Accounting; Address; Administrator; Admission activity; Adrenal Cortex Hormones; Age; Algorithms; Betamethasone; Biometry; Birth; Budgets; Cannulas; Caring; Child; Child health care; Clinical; Clinical Trials; Clinical Trials Design; Companions; Consensus; Consent; Continuous Positive Airway Pressure; DNA; Data Coordinating Center; Discipline of obstetrics; Dose; Educational workshop; Effectiveness; Epithelial; Evaluation; Fetal Lung; Future; Gestational Age; Glucocorticoids; Government; Healthcare Systems; Hospitalization; Hospitals; Hour; Human Development; Icterus; Infant; Institutes; Intramuscular Injections; Life; Masks; Mechanical Ventilators; Membrane; Mission; Morbidity - disease rate; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; Neonatal; Neonatal Intensive Care Units; Newborn Infant; Nose; Nurseries; Outcome; Oxygen; Perinatology; Persons; Placebos; Polymorphism Analysis; Population; Pregnancy; Pregnant Women; Premature Birth; Premature Infant; Premature Labor; Procedures; Production; Provider; Public Health; Randomized; Recommendation; Research; Research Design; Respiratory distress; Respiratory physiology; Risk; Role; Rupture; Sampling; Schedule; Sodium Channel; Steroids; Translating; United States National Institutes of Health; Universities; Washington; Woman; cost; economic impact; epithelial Na+ channel; fetal medicine; health economics; improved; lung development; mortality; natural hypothermia; neonatal death; neonate; premature; primary outcome; public health relevance; randomized trial; receptor; respiratory; response; stillbirth; surfactant; symposium

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(申请人提供)：使用产前类固醇来加速胎肺发育和诱导内源性表面活性物质的产生可能是产科领域改善早产儿结局的最重要的进展之一。1994年NIH协商一致会议的建议是，所有怀孕24周至33周的孕妇，如果在7天内有早产的风险，应被认为是接受单一疗程皮质类固醇产前治疗的对象。然而，早产儿在早产中所占比例相对较小。2005年，超过9%的新生儿出生在34至36周之间，其中三分之一估计患有某种形式的呼吸道疾病。2005年，在国家儿童健康与人类发展研究所(NICHD)为解决这一新出现的问题而举办的讲习班上，为改善结果而提出的建议之一是调查这一“早产晚期”人群产前皮质类固醇的使用情况。这项研究是NICHD MFMU网络的一项合作努力，该网络由NICHD的14个学术临床中心、一个数据协调中心和妊娠与围产期分会组成。拟议的研究设计是一项随机、双盲、临床试验，对象为2800名单胎妊娠妇女，她们在34周0天至36周5天之间自发早产或胎膜破裂，或其护理人员计划在接下来的7天内分娩，不晚于36周6天。怀孕期间曾使用过皮质类固醇的妇女，以及预计在6小时内分娩的妇女将被排除在外。在随机化之前，通过标准化算法来确定孕周。符合条件并征得同意的女性将随机接受两个疗程的肌肉注射，其中包含12毫克的倍他米松，相隔24小时，或接受类似疗程的相同外观的安慰剂。第一剂将在随机化后立即给予。将跟踪所有妇女，直到分娩和新生儿出院，直到出院或出生120天，以较早者为准。综合的主要结果是死产或新生儿在24小时前死亡，或在生命的前72小时内需要新生儿呼吸支持。呼吸支持的定义是连续使用持续正压或湿化的高流量鼻管至少两个小时，连续四个小时的氧耗量至少为FiO2 e 0.3，或使用机械呼吸机。ECMO的使用也包括在主要成果中。总而言之，产前皮质类固醇可能会降低早产儿晚期出生的新生儿的呼吸道发病率，这反过来又可能转化为对儿童健康的持久改善，并减轻卫生保健系统的负担。 与公共卫生相关：过去10年中早产率的增加在一定程度上是由晚产早产的增加推动的，晚产早产的定义是在34至36周之间出生的婴儿。晚期早产儿比足月出生的婴儿更容易出现呼吸窘迫、体温过低和黄疸等并发症，重新入院的频率也更高。产前使用皮质类固醇已被证明可以改善极早产儿的肺功能，但尚未在那些可能在早产后期分娩的婴儿中进行评估。如果证明可以减少对呼吸支持的需求，从而减少特殊护理托儿所的入院率并改善短期结果，公共卫生和经济影响将是相当大的。