Grant: Operating Grant

Preterm birth is the most important cause of infant death and disability in Canada and worldwide. Survival rates of preterm infants are improving but these infants are at substantial risk of medical and neurodevelopmental impairment, including cerebral palsy (CP). MgSO4 given before birth improves the motor outcomes of preterm infants. MgSO4 is inexpensive and used routinely for women with seizures in pregnancy. However, there are ongoing controversies about side effects (such as whether MgSO4-exposed newborns require more resuscitation at birth), inadequately studied outcomes (such as developmental follow-up), and cost. MAG-CP aims to actively manage the national implementation of MgSO4 into clinical practice, explore barriers to change and resolve controversies. MgSO4 use and clinical outcomes will be monitored through the existing Canadian Perinatal Network (CPN) and Canadian Neonatal Follow-Up Network (CNFUN). MAG-CP will include all babies born at <29 wk. These babies are at highest risk of CP and are those with linked data between CPN and the CNFUN. The primary outcome will be use of MgSO4 for neuroprotection as a proportion of eligible women, with a target utilization rate of 80% by the end of 4 years. Other outcomes will include CP, death or CP as a combined outcome, maternal adverse effects, paediatric death, and neurodevelopmental outcomes at 3 years of age. A Data Monitoring Committee will review outcomes and given annual feedback to centres about how they are doing relative to both other centres and rates of outcomes in the published trials. Over 4 yr of managed KT, we anticipate recruitment of 3752 mothers with 2497 children evaluated at 18 mos. This is based on CPN enrollment of 940 babies/yr born at <29 wk, their 83% survival to 18 mos, and 80% parental consent to 18 mos follow-up. This will give us ample power to detect anticipated or important changes in CP and adverse outcomes, even if MgSO4 use reaches only 50% by the end of year 4.