A Phase 3 interventional study of Magnesium sulphate in Cerebral Palsy, sponsored by Hvidovre University Hospital. Completed at 14 sites in Denmark. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Hvidovre University Hospital · Phase 3, Interventional, and Prevention
The purpose of the study is to assess whether magnesium sulphate for women at risk of preterm birth can protect their children against cerebral palsy. The results from this randomised controlled trial will be added to the previous meta-analysis to obtain firm evidence for magnesium sulphate as a neuroprotector, and determine whether it should be used as standard therapy for women in preterm birth.
Cerebral palsy consists of chronic and non-progressive clinical syndromes that are characterized by motor and postural dysfunction. In affected infants, voluntary movements become difficult and limited, and although clinical expression may change with time, this disability is accompanied with major personal and socioeconomic burdens. Preterm infants have increased risk of cerebral palsy, which is inversely correlated with gestational age at birth.
Previous studies have indicated that magnesium sulphate may be neuroprotective for the preterm infant, when the drug is given to women prior to preterm birth.
However, this benefit of antenatal magnesium sulphate was recently questioned by Trial Sequential Analysis (TSA), a statistical method that adjusts for risk of random error on published meta-analyses. TSA demonstrates that additional data are needed before accepting magnesium sulphate as evidence based therapy for women in preterm labour. Therefore we will close the gap by performing a new randomised clinical trial (RCT), which aims to assess whether magnesium sulphate for women prior to preterm birth can protect their children against cerebral palsy.
The RCT will not individually have the power to detect a significant difference between magnesium and placebo. Instead, when the trial is completed, the results will be added to the previous meta-analysis to obtain firm evidence for magnesium sulphate as a neuroprotector, and determine whether it should be used as standard therapy for women in preterm birth.
From Denmark 560 eligible women, who are at risk of preterm birth at 24 to 32 weeks of gestation, will be randomised to receive either intravenous magnesium sulphate or placebo. Randomisation will be performed blinded by computer generated random numbers.
The children are followed up by medical records and by Ages and Stages Questionnaire (ASQ) in the age of 18 month or older. To screen for cerebral palsy, the domains gross motor skills and fine motor skills are together with the total score the most suitable measures.
1,853 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.
This study's enrollment of 560 is above the median of 34 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.
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Magnesium sulphate will be given as a loading dose of 5 g infused for 20-30 minutes, followed by a maintenance dose of 1 g per hour. Placebo will be given in identical appearing doses. The maintenance infusion will be continued until delivery appears, or for 24 hours if delivery does not occur or no longer is considered imminent. The infusion will be resumed when delivery is considered imminent again. Another loading dose of 5 g will be given if at least 6 hours has passed after infusion was stopped. The doses that are used in this project are similar to those used for prevention of eclampsia among women with severe preeclampsia.
Drug: Magnesium sulphate
Placebo and the active drug (Magnesium sulphate) will be administered identically (same loading and maintenance dose for the same period of time).
Drug: Magnesium sulphate
Magnesium sulphate will be given as a loading dose of 5 g infused for 20-30 minutes, followed by a maintenance dose of 1 g per hour. Placebo will be given in identical appearing doses. The maintenance infusion will be continued until delivery appears, or for 24 hours if delivery does not occur or no longer is considered imminent. The infusion will be resumed when delivery is considered imminent again. Another loading dose of 5 g will be given if at least 6 hours has passed after infusion was stopped. The doses that are used in this project are similar to those used for prevention of eclampsia among women with severe preeclampsia.
Also known as: Magnesium sulfat
Moderate or severe cerebral palsy
The difference in the number of children with moderate or severe cerebral palsy at 18 months of age, whose mothers had magnesium sulphate before birth compared to the group of children whose mothers received placebo before birth.
Time frame: At 18 months of age
Perinatal death
The difference in the number of children with perinatal death, whose mothers had magnesium sulphate before birth compared to the group of children whose mothers received placebo before birth.
Time frame: From date of randomization until the date of death from any cause, assessed up to 18 months
Composite outcome of outcome 1 and 2 (moderate-severe cerebral palsy and perinatal death)
Frequency of the composite outcome in the two groups ((intervention and placebo group)
Time frame: At 18 months of age
Blindness
The difference in the number of children with blindness at 18 months of age, whose mothers had magnesium sulphate before birth compared to the group of children whose mothers received placebo before birth.
Time frame: At 18 months of age
Apgar scores
The difference in apgar scores in the group of children, whose mothers had magnesium sulphate before birth compared to the group of children whose mothers received placebo before birth.
Time frame: At 1 minute and 5 minutes after birth
Cranial ultrasound findings
Frequency of intraventricular hemorrhage and periventricular leukomalacia in the two groups ((intervention and placebo group).
Time frame: Assessed up to 18 months of age
Resuscitation in delivery room
Mode of resuscitation in delivery room in the two groups (intervention and placebo group)
Time frame: First hour of life
Neonatal convulsions
Clinically verified convulsions during first neonatal admission.
Time frame: Assessed up to 18 months of age
Use of respiratory support
Endotracheal ventilation or continuous positive airways pressure, or both during first neonatal admission.
Time frame: Assessed up to 18 months of age
Bronchopulmonary dysplasia (BPD)
Mild BPD: Need for continuous, supplemental oxygen at ≥ 28 days but not at 36-week postmenstrual age. Moderate BPD: Need for continuous, supplemental oxygen at 28 days, in addition to supplemental oxygen at ≤30% at 36-week postmenstrual age. Severe BPD: Need for continuous, supplemental oxygen at 28 days and, at 36-week postmenstrual age, the need for mechanical ventilation and/or oxygen \>30%
Time frame: Assessed up to 18 months of age
Hypotension
Need of volume therapy or vasopressors during first neonatal admission.
Time frame: Assessed up to 18 months of age
Length of neonatal hospitalization
Length of the neonatal hospitalization measured in days. From time of birth to discharge after first neonatal admisson or until death.
Time frame: Assessed up to 18 months of age
Retinopathy of prematurity
Retinopathy of prematurity stage 1-5
Time frame: At 18 months of age
Patent ductus arteriosus
Ultrasound verified patent ductus arteriosus
Time frame: At 18 months of age
Necrotizing enterocolitis
Defined according to Bell's critiria
Time frame: Assessed up to 18 months of age
Cerebral palsy
Mild (GMFCS level I), moderate (II-III), severe (IV-V), any
Time frame: At 18 months of age
Blood transfusion
Number of children receiving bood transfusion during first admission
Time frame: Assessed up to 18 months of age
Deafness
One or both ears
Time frame: At 18 months of age
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Hvidovre University Hospital