MGSO4 TOCOLYSIS & RISK OF CEREBRAL PALSY IN VLBW INFANTS

拟议的研究旨在评价可能降低的风险， 极低出生体重儿先天性脑性瘫痪 与硫酸镁（MgSO 4）保胎治疗相关， 早产的常见产前治疗。 先前的研究结果表明， MgSO 4可能为大幅降低CPP风险带来希望 由于未知因素而处于特别高风险的儿童中， 与他们的不成熟和VLBW有关。 严重的局限性， 现有的研究需要在更大的研究中进行复制， 样本量足以检验关联假设并评估 真让人困惑 采用回顾性病例对照设计， 排除在通常情况下不符合资格的妇女的办法 产科实践，接受住院保胎治疗，医疗 从出生的七年开始， （1988-1994年）和17家大型医院在加州，提供专门的 照顾新生儿。 服务机构和新生儿随访数据将 审查，以确定儿童与CP和核实没有CP， 对照 样本量将足以检验以下主要假设 与子宫内MgSO 4暴露相关的风险降低， 90%的范围。 这项研究的主要目的是复制 从以前的小规模观察性研究中发现， 对潜在风险降低的精确估计。 该研究还将 检查常见孕产妇医学检查的混杂因素和效应修正 条件，有效胎龄和出生体重范围，临床 暴露新生儿的特征和剂量反应。 病例对照 设计还允许对CP的其他建议风险因素进行评估。 研究人群包括2岁以下的独生子女幸存者， 出生体重500-1499克，或出生体重1500-1999克， 胎龄小于33周或不详。 在查明 病例，对照将在250 g内以2：1的比例随机抽样 出生体重分层，以反映病例的出生体重分布。 单变量分析将使用调整的Mantel-Haenszel比值比， 出生体重分层 使用逻辑回归的多变量模型将 构建了 结果将在启动后两年内公布， 项目

The proposed study is designed to evaluate possible reduction in risk of congenital cerebral palsy (CP) in very low birthweight (VLBW) infants associated with tocolytic treatment with magnesium sulfate (MgSO4), a common antenatal treatment for preterm labor. Previous findings suggest that MgSO4 may offer the hope of a substantial reduction in risk of CPP among children who are at especially high risk because of unknown factors associated with their immaturity and VLBW. Serious limitations in these existing studies necessitate replication in a larger study with sufficient sample size to adequately test a hypothesis of association and to evaluate confounding. Using a retrospective case-control design and a two-stage approach to exclude women who would not have been eligible, under usual obstetric practice, to receive in-patient tocolytic treatment, medical record data will be obtained on mother-baby pairs from seven birth years (1988-1994) and 17 large hospitals in California which offer specialized care for newborns. Service agency and neonatal follow-up data will be reviewed to ascertain children with CP and to verify absence of CP in controls. Sample size will be sufficient to test the primary hypothesis of a reduction in risk associated with MgSO4 exposure in utero with power in the range of 90%. The primary purpose of this study is to replicate findings from previous, small observational studies and to provide a more precise estimate of the potential reduction in risk. The study will also examine confounding and effect modification by common maternal medical conditions, effective range of gestational age and birthweight, clinical characteristics of exposed neonates, and dose-response. The case-control design will also permit evaluation of other suggested risk factors for CP. The study population includes singleton survivors to two years of age with birthweight 500-1499 grams, or with birthweight 1500-1999 grams and gestational age lessor than 33 weeks or unknown. After ascertainment of cases, controls will be randomly sampled in a 2:1 ratio within 250 gram birthweight strata to mirror the birthweight distribution of cases. Univariate analyses will utilize Mantel-Haenszel odds rations adjusted for birthweight strata. Multivariate models using logistic regression will be constructed. Results will be available within two years from initiation of project.