Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth

NCT00120588 | Completed Phase 4

• 1 other identifier: 1997/575/HP
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth; Periventricular Leukomalacia; Brain Ischemia; Intracranial Hemorrhages

Keywords

brain protection; white matter injury; neurodevelopmental sequelae; magnesium sulfate; intraventricular hemorrhage

Outcome Measures

Primary Outcomes (3)

• death up to discharge of hospital

• severe white matter injury

• combined death up to discharge and severe white matter injury

Secondary Outcomes (6)

• white matter injury

• cystic periventricular leukomalacia

• topography of cysts

• intraventricular/intraparenchymal haemorrhages

• side effects of magnesium sulfate in mothers and preterm newborns

Interventions

magnesium DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women pregnant with single, twin or triplet very preterm fetuses younger than 33 week's gestational age if birth was expected or planned within 24 hours

You may not qualify if:

• women with vascular disease of pregnancy
• women with severe malformation or chromosomal abnormalities in the fetus
• women with hypotension
• renal insufficiency
• cardiac rhythmic abnormalities
• intake of calcium channel inhibitors
• digitalis or indomethacin less than 24 hours
• persistence of signs of cardiovascular toxicity or tachycardia for more than one hour after cessation of betamimetic intake
• myasthenia
• emergency C section

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Charles-Nicolle hospital

Rouen, Normandy, 76031, France

Location

Related Publications (1)

• 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.

  PMID: 24837863 DERIVED

MeSH Terms

Conditions

Premature Birth; Leukomalacia, Periventricular; Brain Ischemia; Intracranial Hemorrhages

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2005
• First Posted: July 18, 2005
• Study Start: July 1, 1997
• Study Completion: July 1, 2005
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

FR (1)