Table 3.
Primary and secondary neonatal outcomes of individual trials and definitions of selected outcomes.
| Primary and secondary neonatal outcome | Definitions of selected outcomes | |
|---|---|---|
| BEAM |
Primary: combined outcome of stillbirth or infant death by 1 year of age or moderate or severe CP at 2 yrs Secondary: neonatal complications, mild, moderate, and severe CP, stillbirth and infant death, Bayley Scales of Infant Development-II |
CP: presence of at least two out of the following three criteria: minimum 30% delay in gross motor developmental milestones; abnormalities in muscle tone, movement, or deep tendon reflexes; or persistence of primitive, or absence of protective reflexes |
| ACTOMgSO4 |
Primary: total pediatric mortality up to age 2, CP, and a combined outcome of death or CP at 2 yrs Secondary: IVH (grade III or IV), cystic PVL, neurosensory disability |
CP: tone abnormalities and loss of motor function |
| PREMAG |
Primary: fetal or neonatal mortality before hospital discharge, severe WMI, combined outcome of death or severe WMI Secondary: severe or moderate WMI, non-parenchymal hemorrhage, periventricular cavitary lesions and their extensions, neonatal complications, motor and cognitive development at 2 yrs |
Severe WMI: cystic PVL, periventricular parenchymal hemorrhage, or large single unilateral porencephalic cyst (caused by ischemic–hemorrhagic infarction) |
| Magpie |
Primary: combined outcome of death or neurosensory disability (blind, deaf, severe CP, or developmental quotient < -2 standard deviations) at 18 months Secondary: death, neurosensory disability, delayed speech, other disability |
Severe CP: not walking or unlikely to walk unaided at 24 months |
| MagNET | Primary: composite of “adverse pediatric health outcomes” (neonatal IVH, PVL, CP or death) by 18 months of age |
CP=cerebral palsy, IVH=intraventricular hemorrhage, PVL=periventricular leukomalacia, WMI=white matter injury