Efficacy of Maternal Magnesium Sulfate Administration on the Neurodevelopmental Outcome of Preterm Babies: A Randomised Controlled Trial

Abstract

Introduction: Cerebral Palsy (CP) is a disability which shows an increased incidence with prematurity and Low Birth Weight (LBW). Many studies suggest that Magnesium Sulfate (MgSO4 ) given to mothers expected to deliver preterm improves their neurodevelopmental outcome. Aim: To assess the role of administration of MgSO4 in improving neurodevelopmental outcome in preterm babies. Materials and Methods: This was a hospital-based, prospective interventional study open label, randomised controlled trial conducted from December 2015 to May 2016 in the Department of Neonatology at Jubilee Mission Medical College in Central Kerala, India. Randomisation was done in deliveries expected to occur at or below 34 weeks. The mothers were then divided into two groups, those who would receive either MgSO4 or a placebo (normal saline). A total of 83 babies were compared for their baseline characteristics, and the association of MgSO4 administration on neonatal mortality, and on Amiel-Tison angle abnormalities and developmental delay at six months was studied. Either Chi-square test or Fisher’s exact test was used to compare the percentages. Microsoft excel was used to enter data. IBM Statistical Package for the Social Science (SPSS) version 21.0 was used for analysis. Statistical significance was considered for p-value <0.05. Results: Both groups were comparable on baseline characteristics. MgSO4 use in mothers was not significantly associated with reduction in neonatal mortality (p-value=0.205). At six months of age, use of MgSO4 was associated with significant reduction in Amiel-Tison angle abnormalities (p-value <0.001), and reduction in developmental delay as assessed by Trivandrum development Screening Chart (p-value <0.001), showing that MgSO4 has a neuroprotective role. Conclusion: Although the percentage of neonatal deaths in the MgSO4 group were less, it was not statistically significant. AmielTison angle abnormalities were significantly less in the group which received MgSO4 . Neurodevelopmental outcome as assessed by TDSC was also significantly less in the group which received MgSO4 . This suggests that antenatal MgSO4 protects preterm babies from cerebral palsy and neurodevelopmental disabilities. A larger study with a longer follow-up is suggested to confirm these findings.