In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants (MgSO4)
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| ClinicalTrials.gov Identifier: NCT01203501 |
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Recruitment Status :
Completed
First Posted : September 16, 2010
Last Update Posted : September 26, 2017
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Sponsor:
NICHD Neonatal Research Network
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network
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Brief Summary:
This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database whose mothers were given prenatal MgSO4, data were prospectively collected on maternal/infant conditions and magnesium exposure (including indications, timing and duration of exposure).
| Condition or disease |
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| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Intracranial Hemorrhages Leukomalacia, Periventricular Cerebral Palsy |
Retrospective studies suggested that the risk of cerebral palsy and intraventricular hemorrhage (IVH) in extremely premature infants of mothers given magnesium sulfate (MgSO4) may be reduced. The purpose of this study was to examine the effects of MgSO4 exposure on adverse outcomes in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database, data were prospectively collected on maternal/infant conditions and MgSO4 exposure (including indications, timing and duration of exposure).
| Study Type : | Observational |
| Actual Enrollment : | 1339 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight (ELBW) Infants |
| Study Start Date : | July 1996 |
| Actual Primary Completion Date : | June 1998 |
| Actual Study Completion Date : | June 2000 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Incidence of Intraventricular Hemorrhage [ Time Frame: Hospital discharge 120 days of life ]
Secondary Outcome Measures :
- Incidence of cerebral palsy [ Time Frame: 18-22 months corrected age ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 14 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
All infants with birth weights 401 through 1500 grams admitted to the NICU within 14 days of age are eligible for the study. In addition, all inborn, liveborn infants in the same weight range (401-1500 gms) who die prior to admission to the NICU are enrolled posthumously.
Criteria
Inclusion Criteria:
- Infants born in NRN Centers with a birth weight of 401-1,500g
Exclusion Criteria:
- None
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203501
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, D.C., District of Columbia, United States, 20052 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Harvard University | |
| Cambridge, Massachusetts, United States, 02138 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Investigators
| Study Director: | James A. Lemons, MD | Indiana University | |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | William Oh, MD | Brown University, Womens and Infants Hospital | |
| Principal Investigator: | Avroy A. Fanaroff, MD | Case Western Reserve University, Rainbow Babies & Children's Hospital | |
| Principal Investigator: | Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University | |
| Principal Investigator: | Ann R. Stark, MD | Brigham and Women's Hospital | |
| Principal Investigator: | Charles R. Bauer, MD | University of Miami | |
| Principal Investigator: | Lu-Ann Papile, MD | University of New Mexico | |
| Principal Investigator: | David K. Stevenson, MD | Stanford University | |
| Principal Investigator: | Sheldon B. Korones, MD | University of Tennessee | |
| Principal Investigator: | Jon E. Tyson, MD MPH | University of Texas Southwestern Medical Center | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University | |
| Principal Investigator: | Raymond Bain, PhD | George Washington University |
Additional Information:
Keywords provided by NICHD Neonatal Research Network:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity Antenatal Magnesium sulfate |
Additional relevant MeSH terms:
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Cerebral Palsy Intracranial Hemorrhages Leukomalacia, Periventricular Body Weight Hemorrhage Birth Weight Pathologic Processes Brain Damage, Chronic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Encephalomalacia Infant, Premature, Diseases Infant, Newborn, Diseases |