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

Primary Purpose

Preterm Birth, Periventricular Leukomalacia, Brain Ischemia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
magnesium
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring brain protection, white matter injury, neurodevelopmental sequelae, magnesium sulfate, intraventricular hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charles-Nicolle hospital

Outcomes

Primary Outcome Measures

death up to discharge of hospital
severe white matter injury
combined death up to discharge and severe white matter injury

Secondary Outcome Measures

white matter injury
cystic periventricular leukomalacia
topography of cysts
intraventricular/intraparenchymal haemorrhages
side effects of magnesium sulfate in mothers and preterm newborns
follow-up at two years of age

Full Information

First Posted
July 11, 2005
Last Updated
June 17, 2013
Sponsor
University Hospital, Rouen
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00120588
Brief Title
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

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Periventricular Leukomalacia, Brain Ischemia, Intracranial Hemorrhages
Keywords
brain protection, white matter injury, neurodevelopmental sequelae, magnesium sulfate, intraventricular hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
700 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
magnesium
Primary Outcome Measure Information:
Title
death up to discharge of hospital
Title
severe white matter injury
Title
combined death up to discharge and severe white matter injury
Secondary Outcome Measure Information:
Title
white matter injury
Title
cystic periventricular leukomalacia
Title
topography of cysts
Title
intraventricular/intraparenchymal haemorrhages
Title
side effects of magnesium sulfate in mothers and preterm newborns
Title
follow-up at two years of age

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane MARRET, MD-PhD
Organizational Affiliation
university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephane Marret, MD-PhD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques Benichou, MD-PhD
Organizational Affiliation
University hopsital of Rouen
Official's Role
Study Director
Facility Information:
Facility Name
Charles-Nicolle hospital
City
Rouen
State/Province
Normandy
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24837863
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.
Results Reference
derived

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

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