|
Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial) Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial) Clinical research trials and Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial) health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial). Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial) Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial) clinical trial. Human subjects frequently get the finest healthcare available for their Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial) condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)  Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
For Condition: Cerebral Palsy,Pulmonary Edema,Intraventricular hemorrhage,Abruptio Placentae,Periventricular Leukomalacia
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute of Neurological Disorders and Stroke (NINDS)
Synopsis: As many more premature infants survive, the numbers of these infants with health problems also has increased. The rate of cerebral palsy in extremely premature infants is approximately 20%. Magnesium sulfate, the most commonly used drug in the US used 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.
Details: 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 24.0 to 31.6 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). 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 > 34.0 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Pregnant with diagnosis of preterm labor - Membrane rupture or delivery definitely planned with 24 hours - Gestational age > 24.0 and < 31.6 wks, viable fetus Exclusion Criteria: - Prior IV magnesium sulfate therapy within 12 hours of screening - Delivery expected <2 hrs - Cervical dilation > 8 cm - More than 2 fetuses - Known major fetal anomalies - Hypertension or preeclampsia - Maternal medical complications contraindicating magnesium sulfate treatment - Participation in any intervention study which influences infant neurological outcome - Previous participation in this trial
Total Enrollment: 2000
Location and Contact Information:
Overall Study Official:
DwightRouse, Principal Investigator, University of Alabama, Birmingham
Case Western University *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Cyndi Milluzzi 216-778-8094
Dept of OB/GYN, University of Miami *No longer recruiting*
Miami, Florida, 33136
United States
No longer recruiting
MCP Hahnemann University *Recruiting*
Philadelphia, Pennsylvania, 19102
United States
Recruiting Mary Talucci 215-762-3273
Women and Infants Hospital *Recruiting*
Providence, Rhode Island, 02905-2499
United States
Recruiting JoAnn Tillinghast 401-274-1100
The University Hospital, University of Cincinnati *No longer recruiting*
Cincinnati, Ohio, 45267-0794
United States
No longer recruiting
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Gail Mallett 312-929-3876
University of North Carolina *Recruiting*
Chapel Hill, North Carolina, 27599
United States
Recruiting Karen Dorman 919-966-2550
Dept of OB/GYN, Southwestern Medical Center, University of Texas *Recruiting*
Dallas, Texas, 75235-9032
United States
Recruiting Julia McCampbell 214-648-2591
Forsyth Memorial Hospital, Wake Forest University School of Medicine *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting Melissa Swain 336-718-5343
University of Utah Medical Center *Recruiting*
Salt Lake City, Utah, 84132
United States
Recruiting Kris Anderson 801-585-5586
St. Luke's - Roosevelt Hospital *Recruiting*
New York City, New York, 10019
United States
Recruiting Vicki Pemberton 212-342-3056
Dept of OB/GYN Magee Womens Hospital *No longer recruiting*
Pittsburgh, Pennsylvania, 15213
United States
No longer recruiting
University of Texas - Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting Mary Day 713-500-6419
Dept of OB/GYN, Hutzel Hospital *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Gwendolyn Norman 313-745-7333
University of Alabama *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Allison Northen 205-934-1322
Dept of OB/GYN, Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Francee Johnson 614-293-8993
University of Texas Medical Branch - Galveston *Recruiting*
Galveston, Texas, 77555
United States
Recruiting Elizabeth Martin 409-747-1733
Additional Information:
Study ID Numbers: NICHD-0800; U10-HD27905,U10-HD34116,U10-HD21410,U10-HD27860,U10-HD34136,U10-HD40473,U10-HD27917,U10-HD27915,U10-HD34208,U10-HD40462
Study Start Date: December 1997
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014989
Other Intraventricular Hemorrhage Studies:
1. Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
Related Studies:
Other Intraventricular hemorrhage Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
|
|
|
|
|
|
|
|
