Table 3.
Human studies of MgSO4 for preterm and term/late preterm neuroprotection.
| References | Indication | Age at birth | Age at study | Timing | Pathology | Function | Sex | Study type |
|---|---|---|---|---|---|---|---|---|
| (31) | Preterm neuroTx: chorioamnionitis | ≤ 30 weeks, n = 228 | 2 y | Antenatal | No difference in rates of IVH between CA+MgSO4 vs. CA+placebo | No difference in rates of CP, mental or physical disability | ✓ | Prospective, double blinded multicenter RCT |
| (32) | Preterm neuroTx: chorioamnionitis | ≥24 weeks n = 396 | 2 y | Antenatal | No difference in rates of IVH or PVL between CA+MgSO4 vs. CA+placebo | No difference in rate of stillbirth, death, moderate-severe CP or neurodevelopmental delay between groups | ✓ | Prospective, double blinded multicenter RCT |
| (33) | Preterm neuroTx | Mean ±SD: 28.3 ±2.2 weeks, n = 73 | Mean ±SD: 32.4 ± 2 weeks | Antenatal | MRI: ↓ cerebellar hemorrhage in MgsO4 (n = 13/49) vs. control (n = 14/24), no effect on white matter injury or IVH | None | ✓ | Prospective, blinded single center study |
| (34) | Preterm neuroTx | Median ± SD: 27 ± 2, weeks, n = 64 | 24, 48, 72 h | Antenatal | Cranial ultrasound: ↓P/IVH in MgSO4 (n = 4/36) vs. vehicle (n = 9/28) at 72 h | NIRS: ↓cerebral O2 consumption vs. vehicle at 24 h | ✓ | Observational single center study |
| (13) | Preterm neuroTx | Mean ± SD: 27.3 ± 2.2, weeks n = 867 | 7–8 years old | Antenatal | None | No difference in cognitive, behavioral, growth or functional outcomes | ✓ | Prospective, double blinded multicenter RCT |
| (12) | Preterm neuroTx | 27–32 weeks n = 501 | 7–14 years old | Antenatal | None | No significant improvement in motor dysfunction, behavior or cognition | ✓ | Prospective, double blinded multicenter RCT |
| (35) | Preterm neuroTx | 24–32 weeks, n = 475 | Hospital discharge | Antenatal | No difference in rates of IVH or PVL. Secondary outcomes showed higher incidence of ROP. Subgroup analysis showed higher neonatal mortality rate with increasing magnesium levels | MgSO4 group took longer to reach full feeds and had greater length of hospital stay vs. placebo | ✓ | Retrospective study |
| (36) | Term HIE | ≥35 weeks n = 60 | Not stated, assessed at hospital discharge | ≤ 6 h after birth | No difference in HIE severity, intracranial hemorrhage or death between MgSO4+HT (n = 29) vs. vehicle+HT (n = 31) | No difference in seizures | χ | Prospective, double blinded multicenter RCT |
| (37) | Term HIE | 38–39 weeks, n = 32 | Follow up to 6 months | ≤ 30 min, 24 and 48 h after birth | Brian CT: No difference in severity of HIE in MgSO4 (n = 16) vs. control (n = 16) | No difference in incidence of death, seizures, discontinuous EEG or neurodevelopmental assessments at discharge and 6 months | χ | Prospective single center RCT |
CA, chorioamnionitis; CP, cerebral palsy; CT, computed tomography; EEG, electroencephalography; HIE, hypoxic ischemic encephalopathy; P/IVH, peri/intraventricular hemorrhage; NIRS, near infrared spectroscopy; PVL, periventricular leukomalacia; RCT, randomized controlled trial; Tx, treatment.