Does magnesium sulphate prevent cerebral palsy in very preterm born infants?

Administration of antenatal magnesium sulphate for prevention of cerebral palsy in preterm infants (MASP-STUDY)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000735-80-DK

Enrollment

560

Registered

2011-03-21

Start date

2011-05-16

Completion date

Unknown

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe cerebral palsy

Interventions

Trade Name: Magnesium sulfat Product Name: Magnesium Sulfat Pharmaceutical Form: Solution for infusion INN or Proposed INN: MAGNESIUM Other descriptive name: Magnesium Sulphate Concentration unit: mmo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women aged 18 years or older were eligible if they were pregnant with singletons or twins and were expected to give birth within 24 hours at gestational age 24+0 to 31+6 weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 560 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Major fetal anomalies, maternal contraindication to Mgso4, MgSO4 administrated for other reasons (preeclampsia), lack of ability ot read and speak Danish

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether magnesium sulphate given to women at imminent risk of preterm birth can prevent cerebral palsy. The results from this RCT will be added to a previous meta-analysis to obtain firm evidence for magnesium sulphate as a neuroprotector.;Secondary Objective: Secondary endpoints are: blindness, composite outcome of cerebral palsy and death, perinatal death, intraventricular hemorrhage, periventricular leukomalacia, Apgar score less than seven after five minutes, need for active resuscitation (assisted ventilation, compression etc.) at birth, neonatal convulsions, use of respiratory support (mechanical ventilation or continuous positive airway pressure or both, chronic lung disease (need for continuous supplemental oxygen at 28 days postnatal or 36 weeks’ postmenopausal age, infection, hypotension, retinopathy of prematurity, necrotizing enterocolitis, deafness, length of neonatal hospitalization, patent ductus arteriosus, use of antibiotics.;Primary end point(s): Moderate-severe cerebral palsy;Timepoint(s) of evaluation of this end point: Minimum 18 months	—

Measure

Time frame

Main Objective: To assess whether magnesium sulphate given to women at imminent risk of preterm birth can prevent cerebral palsy. The results from this RCT will be added to a previous meta-analysis to obtain firm evidence for magnesium sulphate as a neuroprotector.;Secondary Objective: Secondary endpoints are: blindness, composite outcome of cerebral palsy and death, perinatal death, intraventricular hemorrhage, periventricular leukomalacia, Apgar score less than seven after five minutes, need for active resuscitation (assisted ventilation, compression etc.) at birth, neonatal convulsions, use of respiratory support (mechanical ventilation or continuous positive airway pressure or both, chronic lung disease (need for continuous supplemental oxygen at 28 days postnatal or 36 weeks’ postmenopausal age, infection, hypotension, retinopathy of prematurity, necrotizing enterocolitis, deafness, length of neonatal hospitalization, patent ductus arteriosus, use of antibiotics.;Primary end point(s): Moderate-severe cerebral palsy;Timepoint(s) of evaluation of this end point: Minimum 18 months

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are: blindness, composite outcome of cerebral palsy and death, perinatal death, intraventricular hemorrhage, periventricular leukomalacia, Apgar score less than seven after five minutes, need for active resuscitation (assisted ventilation, compression etc.) at birth, neonatal convulsions, use of respiratory support (mechanical ventilation or continuous positive airway pressure or both, chronic lung disease (need for continuous supplemental oxygen at 28 days postnatal or 36 weeks’ postmenopausal age, infection, hypotension, retinopathy of prematurity, necrotizing enterocolitis, deafness, length of neonatal hospitalization, patent ductus arteriosus, use of antibiotics.;Timepoint(s) of evaluation of this end point: Minimum 18 moths of age: mortality, composite outcome of CP and mortality, blindness, retinopathy of prematurity, patent ductus arteriosus Apgar scores: after 1,5 and 10 minutes 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 in addition to supplemental oxygen at >30% at 36 week postmenstrual age Other outcomes: from birth to discharge after first neonatal admission	—

Measure

Time frame

Secondary end point(s): Secondary endpoints are: blindness, composite outcome of cerebral palsy and death, perinatal death, intraventricular hemorrhage, periventricular leukomalacia, Apgar score less than seven after five minutes, need for active resuscitation (assisted ventilation, compression etc.) at birth, neonatal convulsions, use of respiratory support (mechanical ventilation or continuous positive airway pressure or both, chronic lung disease (need for continuous supplemental oxygen at 28 days postnatal or 36 weeks’ postmenopausal age, infection, hypotension, retinopathy of prematurity, necrotizing enterocolitis, deafness, length of neonatal hospitalization, patent ductus arteriosus, use of antibiotics.;Timepoint(s) of evaluation of this end point: Minimum 18 moths of age: mortality, composite outcome of CP and mortality, blindness, retinopathy of prematurity, patent ductus arteriosus Apgar scores: after 1,5 and 10 minutes 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 in addition to supplemental oxygen at >30% at 36 week postmenstrual age Other outcomes: from birth to discharge after first neonatal admission

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Countries

Denmark

Contacts

Public ContactHanne Trap Wolf

Hvidovre Hospital

004538623862

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026