Brain InjuriesPhase 3NCT00065949
Magnesium Sulfate to Prevent Brain Injury in Premature Infants
A Phase 3 study testing magnesium sulfate in people with Brain Injuries and Cerebral Palsy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years to 12 hours
- Conditions the study is for
- Brain Injuries, Cerebral Palsy
- What is being tested?
- magnesium sulfate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 1987to Feb 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 12 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Multiple congenital anomalies
- Single congenital anomaly of the central nervous system
- Unlikely to be available for duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Magnesium Prevention of Brain Injury in Preterm Infants
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.
Read the detailed description
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.
- Conditions
- Brain Injuries, Cerebral Palsy
- Being tested
- magnesium sulfate
- Keywords
- Low birthweight infants, Magnesium supplementation, Intracranial hemorrhage, Cystic periventricular leukomalacia, Mental retardation
- Medical subject headings
- Brain Injuries, Cerebral Palsy, Intracranial Hemorrhages, Leukomalacia, Periventricular, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulfateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startAug 1987
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas E. Wiswell, M.D., Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065949
- Sponsor's protocol ID
- HD21453
- Other IDs
- NICHD-13, NICHD-0523, 5R01HD021453
- Status last verified
- May 2003
- First submitted
- 1 Aug 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Caddell JL, Graziani LJ, Wiswell TE, Hsieh HC, Mansmann HC Jr. The possible role of magnesium in protection of premature infants from neurological syndromes and visual impairments and a review of survival of magnesium-exposed premature infants. Magnes Res. 1999 Sep;12(3):201-16.
PubMed 10488476
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Prevention of Brain Injury in Preterm Infants
- ClinicalTrials.gov ID
- NCT00065949
- Acronym / sponsor ID
- HD21453
- Conditions
- Brain Injuries, Cerebral Palsy
- Keywords
- Low birthweight infants, Magnesium supplementation, Intracranial hemorrhage, Cystic periventricular leukomalacia, Mental retardation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Aug 1987
- Study completion
- Feb 2003
- First posted
- 5 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Multiple congenital anomalies
- Single congenital anomaly of the central nervous system
- Unlikely to be available for duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 10488476Caddell JL, Graziani LJ, Wiswell TE, Hsieh HC, Mansmann HC Jr. The possible role of magnesium in protection of premature infants from neurological syndromes and visual impairments and a review of survival of magnesium-exposed premature infants. Magnes Res. 1999 Sep;12(3):201-16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E. Wiswell, M.D. principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing magnesium sulfate in people with Brain Injuries and Cerebral Palsy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00065949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.