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Sponsors and Collaborators: |
University Hospital, Rouen Programme hospitalier de recherche clinique Ministry of Health, France |
Information provided by: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT00120588 |
Magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic and/or inflammatory cerebral lesions. It is associated with a significant reduction of perinatal death and cerebral palsy in some observational studies.
The objective of the study is to assess if prenatal magnesium sulfate given to women at risk of preterm birth before 33 week's gestation is neuroprotective.
Condition | Intervention | Phase |
Preterm Birth Periventricular Leukomalacia Brain Ischemia Intracranial Hemorrhages |
Drug: magnesium |
Phase IV |
Drug Information available for: | Magnesium Magnesium sulfate |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate |
Estimated Enrollment: | 700 |
Study Start Date: | July 1997 |
Estimated Study Completion Date: | July 2005 |
This is a randomized controlled trial at 18 french tertiary hospitals with stratification by center and multiple births in women at risk of preterm birth before 33 week's gestation and without vascular disease of pregnancy.
Women received 4 g of a 0.1 g/ml magnesium sulfate solution or isotonic serum chloride solution (0.9%).
The main outcome measures are rates of mortality up to discharge, of severe white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages on cranial ultrasonographic studies) and of combined death and severe white matter injury.
The secondary outcome measures are rates of white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages and persisting hypechogenicities at 15 day intervals on cranial ultrasonographic studies), follow-up at two years of age
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France, Normandy | |||||
Charles-Nicolle hospital | |||||
Rouen, Normandy, France, 76031 |
University Hospital, Rouen |
Programme hospitalier de recherche clinique |
Ministry of Health, France |
Principal Investigator: | Stephane MARRET, MD-PhD | University |
Principal Investigator: | Stephane Marret, MD-PhD | University Hospital, Rouen |
Study Director: | Jacques Benichou, MD-PhD | University hopsital of Rouen |
Study ID Numbers: | 970575 |
First Received: | July 11, 2005 |
Last Updated: | July 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00120588 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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