Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014989
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2001-04-17
Brief Title:
Beneficial Effects of Antenatal Magnesium Sulfate BEAM Trial
Sponsor:
The George Washington University Biostatistics Center
Organization:
The George Washington University Biostatistics Center
Study Overview
Official Title:
Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate BEAM
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
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:
BEAM
Brief Summary:
As many more premature infants survive the numbers of these infants with health problems increases The rate of cerebral palsy CP in extremely premature infants is approximately 20 Magnesium sulfate the most commonly used drug in the US to stop premature labor may prevent CP This trial tests whether magnesium sulfate given to a woman in labor with a premature fetus 24 to 31 weeks out of 40 will reduce the rate of death or moderate to severe CP in the children at 2 years The children receive ultrasounds of their brains as infants and attend three follow-up visits over two years to assess their health and development
Detailed Description:
The prevalence of cerebral palsy is increasing as the survival rate of extremely premature infants is improving Studies have suggested an apparent association between maternal magnesium sulfate administration and a reduced risk of cerebral palsy Other studies have suggested a possible association between magnesium sulfate and a reduction in neonatal cranial ultrasound abnormalities which may be markers for subsequent development of cerebral palsy
This multicenter trial tests whether prophylactic magnesium sulfate given to women for whom preterm delivery is imminent reduces the risk of death or moderate to severe cerebral palsy in their children Women presenting from 240 to 316 weeks gestation with advanced preterm labor or premature rupture of the membranes pPROM and no recent exposure to magnesium sulfate are randomized to receive either intravenous magnesium sulfate or masked study drug placebo The study drug is administered as a 6 gram loading dose followed by a 2 gramhour infusion or equivalent rate for placebo If after 12 hours delivery has not occurred and is not anticipated the infusion is stopped No other parenteral tocolytics other than the IV medication may be used Retreatment with study medication is given any time labor recurs or delivery is anticipated until gestational age is 340 wks Standard clinical management and therapy is to be maintained for all study patients Patients are assessed for signs of intolerance to the study medications and maternal data are collected up to hospital discharge A sample of venous blood is collected and neonatal cranial ultrasounds are performed Up to three follow-up visits are scheduled over two years where certified examiners masked to study group assignment collect physical and neurological data including a modified Gross Motor Function Classification Scale The Bayley Scales of Infant Development is also administered Cranial ultrasounds are reviewed centrally
The primary outcome is a composite outcome of death or moderate to severe cerebral palsy Secondary outcomes include maternal infectious morbidity pulmonary edema and placental abruption neonatal stillbirth and death intraventricular hemorrhage periventricular leukomalacia neonatal infectious and noninfectious morbidity
This multicenter trial tests whether prophylactic magnesium sulfate given to women for whom preterm delivery is imminent reduces the risk of death or moderate to severe cerebral palsy in their children Women presenting from 240 to 316 weeks gestation with advanced preterm labor or premature rupture of the membranes pPROM and no recent exposure to magnesium sulfate are randomized to receive either intravenous magnesium sulfate or masked study drug placebo The study drug is administered as a 6 gram loading dose followed by a 2 gramhour infusion or equivalent rate for placebo If after 12 hours delivery has not occurred and is not anticipated the infusion is stopped No other parenteral tocolytics other than the IV medication may be used Retreatment with study medication is given any time labor recurs or delivery is anticipated until gestational age is 340 wks Standard clinical management and therapy is to be maintained for all study patients Patients are assessed for signs of intolerance to the study medications and maternal data are collected up to hospital discharge A sample of venous blood is collected and neonatal cranial ultrasounds are performed Up to three follow-up visits are scheduled over two years where certified examiners masked to study group assignment collect physical and neurological data including a modified Gross Motor Function Classification Scale The Bayley Scales of Infant Development is also administered Cranial ultrasounds are reviewed centrally
The primary outcome is a composite outcome of death or moderate to severe cerebral palsy Secondary outcomes include maternal infectious morbidity pulmonary edema and placental abruption neonatal stillbirth and death intraventricular hemorrhage periventricular leukomalacia neonatal infectious and noninfectious morbidity
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 |
|---|---|---|---|
| U10HD040512 | NIH | None | httpsreporternihgovquickSearchU10HD040512 |
| U10HD021414 | NIH | None | None |
| U10HD021410 | NIH | None | None |
| U10HD027905 | NIH | None | None |
| U10HD027917 | NIH | None | None |
| U10HD027860 | NIH | None | None |
| U10HD027915 | NIH | None | None |
| U10HD034116 | NIH | None | None |
| U10HD034208 | NIH | None | None |
| U10HD034136 | NIH | None | None |
| U10HD027869 | NIH | None | None |
| U10HD036801 | NIH | None | None |
| U10HD027861 | NIH | None | None |
| U10HD034122 | NIH | None | None |
| U10HD034210 | NIH | None | None |
| U10HD040500 | NIH | None | None |
| U10HD040485 | NIH | None | None |
| U10HD053097 | NIH | None | None |
| U10HD040544 | NIH | None | None |
| U10HD040545 | NIH | None | None |
| U10HD040560 | NIH | None | None |