Clinical trial NCT00120588: Neuroprotection by Magnesium Sulfate Given to Women at Risk of Very Preterm Birth
Official title: Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Birth
Periventricular Leukomalacia
Brain Ischemia
Intracranial Hemorrhages
Keywords: brain protection
white matter injury
neurodevelopmental sequelae
magnesium sulfate
intraventricular hemorrhage
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-07-18
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: death up to discharge of hospital
measure: severe white matter injury
measure: combined death up to discharge and severe white matter injury
Secondary outcomes:
measure: white matter injury
measure: cystic periventricular leukomalacia
measure: topography of cysts
measure: intraventricular/intraparenchymal haemorrhages
measure: side effects of magnesium sulfate in mothers and preterm newborns
measure: follow-up at two years of age
Other outcomes:
Locations:
city: Rouen
country: France
facility: Charles-Nicolle hospital
state: Normandy
Study officials:
affiliation: university
name: Stephane MARRET, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Stephane Marret, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hopsital of Rouen
name: Jacques Benichou, MD-PhD
role: STUDY_DIRECTOR
References:
citation: 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.