BENEFICIAL EFFECTS OF ANTENATAL MAGNESIUM SULFATE (BEAM STUDY)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。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IV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瘫（CP）发生率方面的有效性。早产入院时开始静脉输注MgSO4，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，输液将在下次入院时恢复。血液样本将分析总Mg、IL-1、IL-6、IL-10、TNF α、GCSF和ICAM-1。在分娩脐带样品将获得类似的措施和T4， TSH，和游离T4。新生儿颅超声将在分娩后3天内进行，婴儿随访将包括6个月、12-14个月和24-28个月的随访。主要结局指标是婴儿死亡率或严重CP的降低。

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.