|
Magnesium Sulfate to Prevent Brain Injury in Premature Infants Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Magnesium Sulfate to Prevent Brain Injury in Premature Infants conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Magnesium Sulfate to Prevent Brain Injury in Premature Infants Clinical research trials and Magnesium Sulfate to Prevent Brain Injury in Premature Infants medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Magnesium Sulfate to Prevent Brain Injury in Premature Infants. Magnesium Sulfate to Prevent Brain Injury in Premature Infants Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Magnesium Sulfate to Prevent Brain Injury in Premature Infants clinical trial. Participants frequently get the best healthcare available for their Magnesium Sulfate to Prevent Brain Injury in Premature Infants condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Magnesium Sulfate to Prevent Brain Injury in Premature Infants  Magnesium Sulfate to Prevent Brain Injury in Premature Infants
Magnesium Sulfate to Prevent Brain Injury in Premature Infants
For Condition: Cerebral Palsy,Brain Injuries
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: Premature infants weighing less than 1500 grams (3.3 lbs) represent approximately 1.3% 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 3.0 mEq/L. 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 1.2-2.3 mEq/L. High Mg therapy consists of using intravenous MgSO4 to maintain higher (nonharmful) serum Mg levels between 3.5-5.5 mEq/L for the first 3 days of life and between 2.5-3.5 mEq/L for the next 4 days. The high Mg infants will subsequently have their serum Mg levels maintained at 2.4+0.3 mEq/L 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /12 Hours
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Born at 23 to 32 weeks’ gestation - Weighs 500 to 1500 grams (1.1 to 3.3 lbs) - Requires mechanical ventilation - Less than 12 hours of age at time of enrollment Exclusion Criteria - Multiple congenital anomalies - Single congenital anomaly of the central nervous system - Unlikely to be available for duration of the study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasWiswell, Principal Investigator, Thomas Jefferson University
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Additional Information:
Study ID Numbers: HD21453; NICHD-13,NICHD-0523,5 RO1 HD21453
Study Start Date: August 1987
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065949
Other Cerebral Palsy Studies:
1. Botulinum Toxin (BOTOX) for Cerebral Palsy
2. Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
3. Magnesium Sulfate to Prevent Brain Injury in Premature Infants
4. Relaxation Training to Decrease Pain and Improve Function in Adolescents with Cerebral Palsy
5. Classification of Cerebral Palsy Subtypes
Related Studies:
Other Cerebral Palsy Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Magnesium Sulfate to Prevent Brain Injury in Premature Infants
|
|
|
|
|
|
|
|
