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A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy.

ABSTRACT: BACKGROUND:Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy. METHODS:In this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbirth or infant death by 1 year of corrected age or moderate or severe cerebral palsy at or beyond 2 years of corrected age. RESULTS:A total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. Follow-up was achieved for 95.6% of the children. The rate of the primary outcome was not significantly different in the magnesium sulfate group and the placebo group (11.3% and 11.7%, respectively; relative risk, 0.97; 95% confidence interval [CI], 0.77 to 1.23). However, in a prespecified secondary analysis, moderate or severe cerebral palsy occurred significantly less frequently in the magnesium sulfate group (1.9% vs. 3.5%; relative risk, 0.55; 95% CI, 0.32 to 0.95). The risk of death did not differ significantly between the groups (9.5% vs. 8.5%; relative risk, 1.12; 95% CI, 0.85 to 1.47). No woman had a life-threatening event. CONCLUSIONS:Fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate or severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. (ClinicalTrials.gov number, NCT00014989.)

SUBMITTER: Rouse DJ

PROVIDER: S-EPMC2803083 | biostudies-literature | 2008 Aug

REPOSITORIES: biostudies-literature

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A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy.

Rouse Dwight J DJ Hirtz Deborah G DG Thom Elizabeth E Varner Michael W MW Spong Catherine Y CY Mercer Brian M BM Iams Jay D JD Wapner Ronald J RJ Sorokin Yoram Y Alexander James M JM Harper Margaret M Thorp John M JM Ramin Susan M SM Malone Fergal D FD Carpenter Marshall M Miodovnik Menachem M Moawad Atef A O'Sullivan Mary J MJ Peaceman Alan M AM Hankins Gary D V GD Langer Oded O Caritis Steve N SN Roberts James M JM

The New England journal of medicine 20080801 9

<h4>Background</h4>Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy.<h4>Methods</h4>In this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbi ...[more]

PMID: 18753646

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Project description:Background Recent research indicates that intensive rehabilitation tends to be effective for children with cerebral palsy (CP). Intensive Neurophysiological Rehabilitation System (INRS) is a multi-component approach that combines various interventions and addresses different functional goals.. This study aimed to examine the effectiveness of the INRS treatment in children with bilateral CP. Methods In this quasi-randomized controlled study, 48 children with spastic bilateral CP (age 5–12 years, GMFCS Levels I-IV, MACS Levels I-IV) were assigned to an experimental or control group in order they have been enrolled. The experimental group underwent INRS treatment in the tertiary care facility for about four hours daily for ten days and continued routine home treatment for four weeks. After the first evaluation, participants from the control group stayed on the waiting list for four weeks receiving home treatment and then starting the INRS treatment. Thereby, all participants were assessed three times. The primary outcome measure was a Gross Motor Function Measure 66 Item Set (GMFM). The secondary outcome measures included the Jebsen-Taylor Hand Function test, Box and Blocks test, ABILHAND-Kids Questionnaire, Self-care and Mobility domain of the Pediatric Evaluation of Disability Inventory, and the ankle dorsiflexion passive range of motion. Results There was a statistically significant increase in the GMFM score after the INRS treatment in both the experimental group (mean difference (MD) 2.0, P < 0.01) and control group (MD 1.5, P < 0.05), with a large size effect (partial eta squared (η2) = 0.21 and η2 = 0.14). The mean difference between groups during the first study period was 2.89 points (p < 0.01) in the GMFM score with a medium effect size (η2 = 0.12). Statistically significant superiority of the INRS treatment over home treatment was also obtained by Jebsen-Taylor Hand Function Test and the Box and Blocks Test in both dominant and non-dominant hands. Conclusions The study indicates that the INRS treatment can be beneficial for improving both gross motor functions and hand function in children with bilateral CP. Further longitudinal studies are required to evaluate the effects of the INRS treatment on the participation level of children with CP. Trial registration The study protocol was registered on ClinicalTrials.gov under the identifier: NCT04093180 on 17/09/2019.

Project description:BackgroundCerebral palsy (CP) is a physical disability that affects movement and posture. Approximately 17 million people worldwide and 34,000 people in Australia are living with CP. In clinical and kinematic research, goniometers and inclinometers are the most commonly used clinical tools to measure joint angles and positions in children with CP.ObjectiveThis paper presents collaborative research between the School of Electrical Engineering, Computing and Mathematical Sciences at Curtin University and a team of clinicians in a multicenter randomized controlled trial involving children with CP. This study aims to develop a digital solution for mass data collection using inertial measurement units (IMUs) and the application of machine learning (ML) to classify the movement features associated with CP to determine the effectiveness of therapy. The results were calculated without the need to measure Euler, quaternion, and joint measurement calculation, reducing the time required to classify the data.MethodsCustom IMUs were developed to record the usual wrist movements of participants in 2 age groups. The first age group consisted of participants approaching 3 years of age, and the second age group consisted of participants approaching 15 years of age. Both groups consisted of participants with and without CP. The IMU data were used to calculate the joint angle of the wrist movement and determine the range of motion. A total of 9 different ML algorithms were used to classify the movement features associated with CP. This classification can also confirm if the current treatment (in this case, the use of wrist extension) is effective.ResultsUpon completion of the project, the wrist joint angle was successfully calculated and validated against Vicon motion capture. In addition, the CP movement was classified as a feature using ML on raw IMU data. The Random Forrest algorithm achieved the highest accuracy of 87.75% for the age range approaching 15 years, and C4.5 decision tree achieved the highest accuracy of 89.39% for the age range approaching 3 years.ConclusionsAnecdotal feedback from Minimising Impairment Trial researchers was positive about the potential for IMUs to contribute accurate data about active range of motion, especially in children, for whom goniometric methods are challenging. There may also be potential to use IMUs for continued monitoring of hand movements throughout the day.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614001276640, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367398; ANZCTR ACTRN12614001275651, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367422.

Project description:BackgroundArterial stiffness is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. Recently, we showed that magnesium citrate supplementation results in a clinically relevant improvement of arterial stiffness. It remained unclear whether the observed effect was due to magnesium or citrate, and whether other magnesium compounds may have similar effects. Therefore, we aim to study the long-term effects of magnesium citrate, magnesium oxide and magnesium sulfate on arterial stiffness. In addition, we aim to investigate possible underlying mechanisms, including changes in blood pressure and changes in gut microbiota diversity.MethodsIn this randomized, double-blind, placebo-controlled trial, a total of 162 healthy overweight and slightly obese men and women will be recruited. During a 24-week intervention, individuals will be randomized to receive: magnesium citrate; magnesium oxide; magnesium sulfate (total daily dose of magnesium for each active treatment 450 mg); or placebo. The primary outcome of the study is arterial stiffness measured by the carotid-femoral pulse wave velocity (PWVc-f), which is the gold standard for quantifying arterial stiffness. Secondary outcomes are office blood pressure, measured by a continuous blood pressure monitoring device, and gut microbiota, measured in fecal samples. Measurements will be performed at baseline and at weeks 2, 12 and 24.DiscussionThe present study is expected to provide evidence for the effects of different available magnesium formulations (organic and inorganic) on well-established cardiovascular risk markers, including arterial stiffness and blood pressure, as well as on the human gut microbiota. As such, the study may contribute to the primary prevention of cardiovascular disease in slightly obese, but otherwise healthy, individuals.Trial registrationClinicalTrials.gov, NCT03632590 . Retrospectively registered on 15 August 2018.

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A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy.

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A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy.

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