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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| death up to discharge of hospital | ||
| severe white matter injury | ||
| combined death up to discharge and severe white matter injury |
| Measure | Description | Time Frame |
|---|---|---|
| white matter injury | ||
| cystic periventricular leukomalacia | ||
| topography of cysts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephane MARRET, MD-PhD | university | Principal Investigator |
| Stephane Marret, MD-PhD | University Hospital, Rouen | Principal Investigator |
| Jacques Benichou, MD-PhD | University hopsital of Rouen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles-Nicolle hospital | Rouen | Normandy | 76031 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24837863 | Derived | Chollat C, Enser M, Houivet E, Provost D, Benichou J, Marpeau L, Marret S. School-age outcomes following a randomized controlled trial of magnesium sulfate for neuroprotection of preterm infants. J Pediatr. 2014 Aug;165(2):398-400.e3. doi: 10.1016/j.jpeds.2014.04.007. Epub 2014 May 14. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007969 | Leukomalacia, Periventricular |
| D002545 | Brain Ischemia |
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| intraventricular/intraparenchymal haemorrhages |
| side effects of magnesium sulfate in mothers and preterm newborns |
| follow-up at two years of age |
| D000091642 | Urogenital Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004678 | Encephalomalacia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |