Deborah G Hirtz1, Steven J Weiner2, Dorothy Bulas3, Michael DiPietro4, Joanna Seibert5, Dwight J Rouse6, Brian M Mercer7, Michael W Varner8, Uma M Reddy9, Jay D Iams10, Ronald J Wapner11, Yoram Sorokin12, John M Thorp13, Susan M Ramin14, Fergal D Malone15, Marshall W Carpenter16, Mary J O'Sullivan17, Alan M Peaceman18, Gary D V Hankins19, Donald Dudley20, Steve N Caritis21. 1. National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD. 2. Biostatistics Center, The George Washington University, Washington, DC. 3. Department of Diagnostic Imaging and Radiology, Children's National Medical Center, Washington, DC. 4. Section of Pediatric Radiology, University of Michigan, Ann Arbor, MI. 5. Division of Radiology, Arkansas Children's Hospital, Little Rock, AR. 6. Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL. 7. Department of Obstetrics and Gynecology, Case Western Reserve University-MetroHealth Medical Center, Cleveland, OH, and University of Tennessee, Memphis, TN. 8. Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, UT. 9. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD. 10. Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH. 11. Department of Obstetrics and Gynecology, Thomas Jefferson University and Drexel University, Philadelphia, PA. 12. Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI. 13. Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC. 14. Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, TX. 15. Department of Obstetrics and Gynecology, Columbia University, New York, NY. 16. Department of Obstetrics and Gynecology, Brown University, Providence, RI. 17. Department of Obstetrics and Gynecology, University of Miami, Miami, FL. 18. Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL. 19. Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX. 20. Department of Obstetrics and Gynecology, University of Texas at San Antonio, San Antonio, TX. 21. Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA.
Abstract
OBJECTIVE: To evaluate the relationship of maternal antenatal magnesium sulfate (MgSO4) with neonatal cranial ultrasound abnormalities and cerebral palsy (CP). STUDY DESIGN: In a randomized trial of MgSO4 or placebo in women at high risk of preterm delivery, up to 3 cranial ultrasounds were obtained in the neonatal period. Images were reviewed by at least 2 pediatric radiologists masked to treatment and other clinical conditions. Diagnoses were predefined for intraventricular hemorrhage, periventricular leukomalacia, intracerebral echolucency or echodensity, and ventriculomegaly. CP was diagnosed at 2 years of age by standardized neurologic examination. RESULTS:Intraventricular hemorrhage, periventricular leukomalacia, intracerebral echolucency or echodensity, and ventriculomegaly were all strongly associated with an increased risk of CP. MgSO4 administration did not affect the risk of cranial ultrasound abnormality observed at 35 weeks postmenstrual age or later. However, for the 82% of infants born at <32 weeks gestation, MgSO4 was associated with a reduction in risk of echolucency or echodensity. The reduction in risk for echolucency explained 21% of the effect of MgSO4 on CP (P = .04), and for echodensity explained 20% of the effect (P = .02). CONCLUSIONS:MgSO4 given prior to preterm delivery was associated with decreased risk of developing echodensities and echolucencies at <32 weeks gestation. However, this effect can only partially explain the effect of MgSO4 on CP at 2 years of age. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00014989. Published by Elsevier Inc.
RCT Entities:
OBJECTIVE: To evaluate the relationship of maternal antenatal magnesium sulfate (MgSO4) with neonatal cranial ultrasound abnormalities and cerebral palsy (CP). STUDY DESIGN: In a randomized trial of MgSO4 or placebo in women at high risk of preterm delivery, up to 3 cranial ultrasounds were obtained in the neonatal period. Images were reviewed by at least 2 pediatric radiologists masked to treatment and other clinical conditions. Diagnoses were predefined for intraventricular hemorrhage, periventricular leukomalacia, intracerebral echolucency or echodensity, and ventriculomegaly. CP was diagnosed at 2 years of age by standardized neurologic examination. RESULTS: Intraventricular hemorrhage, periventricular leukomalacia, intracerebral echolucency or echodensity, and ventriculomegaly were all strongly associated with an increased risk of CP. MgSO4 administration did not affect the risk of cranial ultrasound abnormality observed at 35 weeks postmenstrual age or later. However, for the 82% of infants born at <32 weeks gestation, MgSO4 was associated with a reduction in risk of echolucency or echodensity. The reduction in risk for echolucency explained 21% of the effect of MgSO4 on CP (P = .04), and for echodensity explained 20% of the effect (P = .02). CONCLUSIONS:MgSO4 given prior to preterm delivery was associated with decreased risk of developing echodensities and echolucencies at <32 weeks gestation. However, this effect can only partially explain the effect of MgSO4 on CP at 2 years of age. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00014989. Published by Elsevier Inc.
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