title: School-age outcomes of very preterm infants after antenatal treatment with magnesium sulfate vs placebo.
abstract: OBJECTIVE
  Antenatal magnesium sulfate given to pregnant women at imminent risk of very preterm delivery reduces the risk of cerebral palsy in early childhood, although its effects into school age have not been reported from randomized trials.
  
  
  OBJECTIVE
  To determine the association between exposure to antenatal magnesium sulfate and neurological, cognitive, academic, and behavioral outcomes at school age.
  
  
  METHODS
  The ACTOMgSO4 was a randomized clinical trial conducted in 16 centers in Australia and New Zealand, comparing magnesium sulfate with placebo given to pregnant women (n = 535 magnesium; n = 527 placebo) for whom imminent birth was planned or expected before 30 weeks' gestation. Children who survived from the 14 centers who participated in the school-age follow-up (n = 443 magnesium; n = 424 placebo) were invited for an assessment at 6 to 11 years of age between 2005 and 2011.
  
  
  METHODS
  Mortality, cerebral palsy, motor function, IQ, basic academic skills, attention and executive function, behavior, growth, and functional outcomes. Main analyses were imputed for missing data.
  
  
  RESULTS
  Of the 1255 fetuses known to be alive at randomization, the mortality rate to school age was 14% (88/629) in the magnesium sulfate group and 18% (110/626) in the placebo group (risk ratio [RR], 0.80; 95% CI, 0.62-1.03, P = .08). Of 867 survivors available for follow-up, outcomes at school age (corrected age 6-11 years) were determined for 669 (77%). Comparing the magnesium sulfate and placebo groups revealed no statistically significant difference in proportions with cerebral palsy (23/295 [8%] and 21/314 [7%], respectively; odds ratio [OR], 1.26; 95% CI, 0.84-1.91; P = .27) or abnormal motor function (80/297 [27%] and 80/300 [27%], respectively; OR, 1.16; 95% CI, 0.88-1.52; P = .28). There was also little difference between groups on any of the cognitive, behavioral, growth, or functional outcomes.
  
  
  CONCLUSIONS
  Magnesium sulfate given to pregnant women at imminent risk of birth before 30 weeks' gestation was not associated with neurological, cognitive, behavioral, growth, or functional outcomes in their children at school age, although a mortality advantage cannot be excluded. The lack of long-term benefit requires confirmation in additional studies.
  
  
  BACKGROUND
  anzctr.org.au Identifier: ACTRN12606000252516.
authors.affiliation: Departments of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia2Paediatrics, University of Melbourne, Melbourne, Australia3The Royal Women's Hospital, Melbourne, Australia4Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Lex W
authors.initials: LW
authors.lastname: Doyle
authors.affiliation: Departments of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia2Paediatrics, University of Melbourne, Melbourne, Australia4Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Anderson
authors.affiliation: Women's and Children's Hospital, Adelaide, Australia6Discipline of Obstetrics and Gynaecology, University of Adelaide, Adelaide, Australia.
authors.forename: Ross
authors.initials: R
authors.lastname: Haslam
authors.affiliation: Paediatrics, University of Melbourne, Melbourne, Australia4Murdoch Childrens Research Institute, Melbourne, Australia.
authors.forename: Katherine J
authors.initials: KJ
authors.lastname: Lee
authors.affiliation: Liggins Institute, University of Auckland, Auckland, New Zealand8Australian Research Centre for Women and Babies, Robinson Research Institute, University of Adelaide, Adelaide, Australia.
authors.forename: Caroline
authors.initials: C
authors.lastname: Crowther
mesh_terms: D002547:Cerebral Palsy / Q000517:prevention & control*; D002657:Child Development; D003072:Cognition Disorders / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007226:Infant Mortality; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D008278:Magnesium Sulfate / Q000627:therapeutic use*; D008297:Male; D019957:Motor Skills Disorders / Q000517:prevention & control*; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D011247:Pregnancy; D047928:Premature Birth; D011295:Prenatal Care; D016896:Treatment Outcome
chemical_list: D018696:Neuroprotective Agents; D008278:Magnesium Sulfate