BENEFICIAL EFFECTS OF ANTENATAL MAGNESIUM SULFATE (BEAM STUDY)

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项随机、双盲、安慰剂对照的前瞻性多中心试验，旨在探讨静脉注射硫酸镁(MGS04)在降低胎膜早破(PROM)或早产母亲所生儿童死亡或脑性瘫痪(CP)发生率方面的有效性。静脉输注硫酸镁将在早产入院时开始，并持续至少12小时或直到分娩，以先到者为准。如果婴儿没有出生，母亲出院，下一次入院时将恢复输液。血样将分析总镁、IL-1、IL-6、IL-10、肿瘤坏死因子α、GCSF和ICAM-1。在交付时，将获得用于类似测量的脐带样本以及T4、TSH和游离T4。新生儿将在分娩后3天内进行头颅超声检查，婴儿随访将包括6个月、12-14个月和24-28个月。主要的结果衡量标准是婴儿死亡率或严重脑瘫的减少。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a randomized, double-blind placebo controlled prospective multi-center trial designed to address the effectiveness of IV magnesium sulfate (MgS04) on reducing the incidence of death or the development of cerebral palsy (CP) in children born to mothers with premature rupture of membranes (PROM) or preterm labor. IV infusion of MgSO4 will be started on admission with preterm labor and continued for at least 12 hours or until delivery, whichever comes first. If the baby is not delivered and the mother is discharged, infusion will be resumed on the next admission. A blood sample will be analyzed for total Mg, IL-1, IL-6, IL-10, TNF alpha, GCSF and ICAM-1. At delivery a cord sample will be obtained for similar measures and T4, TSH, and free T4. Neonatal cranial ultrasounds will be performed within 3 days of delivery and infant follow-up will include visits at 6, 12-14, and 24-28 months. The primary outcome measure is a reduction in infant mortality or severe CP.