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

基本信息

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
项目类别：
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

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肺发育并诱导内源性表面活性剂产生可能是产科领域改善极早产新生儿结局的最重要进展之一。 1994 年 NIH 共识会议的建议是，所有妊娠 24 至 33 周且有 7 天内早产风险的孕妇应考虑接受单疗程皮质类固醇产前治疗。然而，极早产儿仅占早产的一小部分。 2005 年，超过 9% 的新生儿出生时间在 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，在国家儿童健康和人类发展研究所 (NICHD) 为解决这一新问题而举办的研讨会上，为改善结果而提出的建议之一是调查产前皮质类固醇在“晚期早产”人群中的使用情况。这项研究是 NICHD MFMU 网络的合作成果，该网络由 NICHD 的 14 个学术临床中心、一个数据协调中心以及妊娠和围产期分部组成。拟议的研究设计是一项随机、双盲临床试验，受试者为 2800 名单胎妊娠妇女，这些妇女年龄在 34 周 0 天至 36 周 5 天之间，有自发性早产或胎膜破裂，或其护理人员已安排分娩放置在接下来的 7 天内，并且不晚于 36 周 6 天。怀孕期间曾使用过皮质类固醇的女性以及预计在 6 小时内分娩的女性将被排除在外。孕龄是在随机化之前通过标准化算法确定的。符合条件并同意的女性将被随机分配接受两次含有 12 毫克倍他米松的肌肉注射疗程，间隔 24 小时，或接受类似疗程的外观相同的安慰剂。第一剂将在随机分组后立即注射。所有妇女均将接受随访，直至分娩后出院，新生儿将接受随访直至出院或 120 天大（以较早者为准）。复合主要结局是死产或新生儿在 24 小时内死亡，或新生儿在出生后 72 小时内需要呼吸支持。呼吸支持的定义是至少连续两个小时使用持续气道正压通气或加湿高流量鼻插管，至少连续四个小时的氧气需求量 FiO2 e 0.3，或使用机械呼吸机。 ECMO 的使用也包含在主要结局中。总之，产前皮质类固醇可能会降低早产后期出生的新生儿的呼吸系统发病率，这反过来又可以转化为儿童健康的持久改善，并减轻医疗保健系统的负担。公共卫生相关性：过去 10 年早产率的增加部分是由于晚期早产（定义为 34 至 36 周之间的分娩）的增加所致。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，并且再次入院的频率更高。产前皮质类固醇的使用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。如果能够减少对呼吸支持的需求，从而降低特殊护理托儿所的入院率并改善短期结果，那么对公共卫生和经济的影响将是相当大的。