A Phase 3 interventional study of magnesium sulfate in Cerebral Palsy, Intraventricular Hemorrhage and Periventricular Leukomalacia, sponsored by The George Washington University Biostatistics Center. Completed at 17 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2019-07-12.
Sponsored by The George Washington University Biostatistics Center · Phase 3, Interventional, and Prevention
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Among 372 studies in Cerebral Palsy with a site in United States — 76 open to participants now, 104 under way, none of them phase 3. Cerebral Palsy · United States.
Among the 372 studies in Cerebral Palsy with a site in United States, this one has the largest enrollment of the 296 interventional ones that give a count, is one of 2 that started in 1997, is one of 17 in phase 3, and was the 2nd registered.
1,937 studies on the registry are indexed under Cerebral Palsy; 457 are open to participants now.
Browse Cerebral Palsy studies →76 of the 372 studies in Cerebral Palsy with a site in United States are open now. Recruiting first, the newest first:
The Foundation for Orthopaedics and Regenerative Medicine · Sites in United States, Greece
University of Washington · Sites in United States
Ages 4–65
University of Wisconsin, Madison · Sites in United States
Ages 7–17
Columbia University · Sites in United States
Ages 18–80
Martin Piazza · Sites in United States
Ages 3–14
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 269 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 234 (87%) stop at 75 or younger; 254 take children under 18; 51 take healthy volunteers.
This study: female · no healthy volunteers.
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372 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 36 · Phase 2 31 · Phase 3 18 · Phase 4 7
First in 1987; this study’s year is marked. 2 started in 1997.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,136 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Median enrollment 25 across the 296 interventional studies, 61 across the 71 observational. Of the 225 that completed or were terminated, 83 (37%) have results posted.
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34 of 372 have an industry lead sponsor. The 10 most frequent:
The George Washington University Biostatistics Center is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
The George Washington University Biostatistics Center has 1 study filed under Cerebral Palsy — fewer than ten, so there is no comparison to draw.
25 of the studies in Cerebral Palsy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07516067Martin PiazzaSpinal Cord Stimulation for Children With Cerebral Palsy | 2026-11 |
| NCT04630392Georgia State UniversityEffects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy | 2026-11-20 |
| NCT05339932Grand Valley State UniversityGrand Valley State University (GVSU) Skills on Wheels | 2026-11-30 |
| NCT06377085Shirley Ryan AbilityLabRepurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy | 2026-12 |
| NCT04897347Teachers College, Columbia UniversityRobotic TruST-Postural Intervention for Children With Cerebral Palsy | 2026-12 |
Add all 25 to your calendar (.ics) → With an account.
Among the 372 studies in Cerebral Palsy with a site in United States, from their registry updates:
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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.
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. The study drug is administered as a 6 gram loading dose followed by a 2 gram/hour 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 > 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Composite outcome of death or moderate to severe cerebral palsy
Maternal
Chorioamnionitis
Endometritis
Other infectious morbidity
Pulmonary edema
Placental abruption
Neonatal
Stillbirth and neonatal death
Intraventricular hemorrhage
Neonatal infectious morbidity
Neonatal noninfectious morbidity
Birth weight
Days in NICU
Plan to share: Yes — The data will be shared after completion and publication of the main analyses in accordance with NIH policy. The dataset can be obtained by email at mfmudatasets@bsc.gwu.edu.
The record gives a start of Dec 1997, a primary completion of Feb 2007 and a completion of Jun 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate
The George Washington University Biostatistics Center