Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065949
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-08-01
Brief Title:
Magnesium Sulfate to Prevent Brain Injury in Premature Infants
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Magnesium Prevention of Brain Injury in Preterm Infants
Status:
UNKNOWN
Status Verified Date:
2003-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Premature infants are at risk for acute brain injuries and long-term developmental problems such as cerebral palsy CP Research suggests that high levels of magnesium at and around the time of birth may decrease the risk of brain injuries This study will evaluate the effects of giving magnesium to premature infants
Detailed Description:
Premature infants weighing less than 1500 grams 33 lbs represent approximately 13 of liveborn infants yet comprise at least 25 of all children who are subsequently diagnosed with CP Antepartum exposure to magnesium Mg may prevent or ameliorate early brain injury intracranial hemorrhage and cystic periventricular leukomalacia as well as long-term adverse neurodevelopmental outcomes CP and mental retardation in very low birthweight VLBW preterm infants In preliminary studies short- and long-term neuroprotection were associated with initial serum Mg levels above 30 mEqL This study will determine whether early abnormal neurosonographic findings and long-term adverse neurodevelopmental outcomes in VLBW premature infants are influenced by different levels of serum Mg achieved during the first week of life
Infants will be randomized to either standard Mg therapy or high Mg therapy Standard Mg therapy consists of no supplemental Mg for the first 3 days of life followed by intravenous magnesium sulfate MgSO4 aimed at attaining serum Mg levels in the normal range of 12-23 mEqL High Mg therapy consists of using intravenous MgSO4 to maintain higher nonharmful serum Mg levels between 35-55 mEqL for the first 3 days of life and between 25-35 mEqL for the next 4 days The high Mg infants will subsequently have their serum Mg levels maintained at 2403 mEqL using oral magnesium gluconate for the remainder of their neonatal hospitalization
Infants will be evaluated for early brain injury with head ultrasound studies 12 to 24 hours after birth at 2 to 3 day intervals while ventilator support is required and at weekly intervals until discharge The infants will subsequently be assessed in the high-risk follow-up clinic for a minimum of 24 months corrected for degree of prematurity At 24 months of age they will be evaluated by a pediatric neurologist for the presence of cerebral palsy They will be tested serially for problems in early cognition mental language and perceptual ability as well as fine and gross motor skills
Infants will be randomized to either standard Mg therapy or high Mg therapy Standard Mg therapy consists of no supplemental Mg for the first 3 days of life followed by intravenous magnesium sulfate MgSO4 aimed at attaining serum Mg levels in the normal range of 12-23 mEqL High Mg therapy consists of using intravenous MgSO4 to maintain higher nonharmful serum Mg levels between 35-55 mEqL for the first 3 days of life and between 25-35 mEqL for the next 4 days The high Mg infants will subsequently have their serum Mg levels maintained at 2403 mEqL using oral magnesium gluconate for the remainder of their neonatal hospitalization
Infants will be evaluated for early brain injury with head ultrasound studies 12 to 24 hours after birth at 2 to 3 day intervals while ventilator support is required and at weekly intervals until discharge The infants will subsequently be assessed in the high-risk follow-up clinic for a minimum of 24 months corrected for degree of prematurity At 24 months of age they will be evaluated by a pediatric neurologist for the presence of cerebral palsy They will be tested serially for problems in early cognition mental language and perceptual ability as well as fine and gross motor skills
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HD021453 | NIH | None | httpsreporternihgovquickSearch5R01HD021453 |
| NICHD-13 | None | None | None |
| NICHD-0523 | None | None | None |