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.
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