Trial record 13 of 432 for:
pharmacology + NICHD
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants (MgSO4)
This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203501
First received: September 15, 2010
Last updated: January 9, 2011
Last verified: September 2010
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Purpose
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 |
|---|
|
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Intracranial Hemorrhages Leukomalacia, Periventricular Cerebral Palsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight (ELBW) Infants |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Incidence of Intraventricular Hemorrhage [ Time Frame: Hospital discharge 120 days of life ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of cerebral palsy [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: Yes ]
| Enrollment: | 1339 |
| Study Start Date: | July 1996 |
| Study Completion Date: | June 2000 |
| Primary Completion Date: | June 1998 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | up to 14 Days |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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, 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
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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | James A. Lemons, Lead Principal Investigator, Indiana University |
| ClinicalTrials.gov Identifier: | NCT01203501 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0016, U10HD034216, U10HD027904, U10HD021364, M01RR000080, U10HD027853, M01RR008084, U10HD027851, M01RR000039, U10HD034167, M01RR001032, M01RR002635, U10HD027856, M01RR000750, U10HD021397, U10HD027881, M01RR000997, U10HD027880, M01RR000070, U10HD021415, U10HD021373, M01RR000633, U10HD021385, U10HD027871, M01RR006022 |
| Study First Received: | September 15, 2010 |
| Last Updated: | January 9, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity Antenatal Magnesium sulfate |
Additional relevant MeSH terms:
|
Pharmacologic Actions Molecular Mechanisms of Pharmacological Action Birth Weight Cerebral Palsy Hemorrhage Leukomalacia, Periventricular Intracranial Hemorrhages Body Weight Signs and Symptoms Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Pathologic Processes Cerebrovascular Disorders |
Encephalomalacia Vascular Diseases Cardiovascular Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents |
ClinicalTrials.gov processed this record on May 16, 2013