Meta AnalysisID 3535

硫酸镁治疗新生儿缺氧缺血性脑病

CRD42022338700

To assess the effect of neonatal administration of magnesium sulphate in neonates born from 36 weeks of gestation onwards with hypoxic ischaemic encephalopathy on long-term neurodevelopmental outcomes, and mortality, and

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Meta Analysis Id: 3535
Evidence Id: 12093
Core Evidence Id: 12093
Source Meta Analysis Id: 3491
Herb2 Meta Analysis Id: HBMA003491
Crd Id: CRD42022338700
Title: Magnesium sulphate for neonates with hypoxic ischaemic encephalopathy
Review Question: To assess the effect of neonatal administration of magnesium sulphate in neonates born from 36 weeks of gestation onwards with hypoxic ischaemic encephalopathy on long-term neurodevelopmental outcomes, and mortality, and clinically significant side effects. Secondary objectives include evaluating the adverse effects of postnatal magnesium sulphate administration and effects on early prognostic indicators of adverse outcomes.
Study Type Included: All randomised controlled trials published in English with full data available comparing the use of neonatal magnesium sulphate to standard care (including therapeutic hypothermia) for all neonates diagnosed with hypoxic ischaemic encephalopathy will be reviewed. Cross-over trials will be excluded.
Condition Being Studied: Hypoxic ischaemic encephalopathy (HIE) is one of the main causes of adverse neurological outcomes and mortality in late preterm and term-born infants. In developed countries, the incidence of HIE is 1 to 2 per 1000 live births with recent data from a national population study published in 2022 which included infants born from 34 weeks gestation onwards, showing an incidence of 2.96 per 1000 live births annually in England and Wales. Despite changes in UK national guidance to include therapeutic hypothermia for infants born from 36 weeks of gestation since the TOBY trial was published and a reduction in infant mortality, Shipley et.al found that a large portion, 37.9% of infants diagnosed with moderate or severe HIE did not receive therapeutic hypothermia (TH) due to various reasons including not being within the therapeutic window or too unwell clinically. Follow up from the TOBY trial in childhood found improved neurocognitive outcomes with TH but frequency of adverse neurocognitive outcomes resulting from HIE was still notable. Thus, this highlights an important area to assess adjuncts or alternatives to TH in view of reducing infant mortality and improving immediate and long-term neurocognitive outcomes.
Participant: Studies enrolling, or results available on: 1. Term neonates with a gestational age at birth greater than or equal to 36 weeks. 2. Evidence of asphyxia, using one, or more, of the following criteria: a. An Apgar score less than or equal to 5 at 10 minutes; b. Resuscitation, including need for endotracheal or mask ventilation resuscitation at 10 minutes; c. Cord or arterial pH less than 7.00 or base deficit greater than or equal to 16 within 60 minutes of birth. 3. Evidence of encephalopathy as per Sarnat, or compatible staging: a. Stage 1 (mild): hyperalert, hyperreflexia, mydriasis, tachycardic, no seizures; b. Stage 2 (moderate): lethargic, hyperreflexia, miosis, bradycardic, seizures, hypotonia with weak suck and Moro; c. Stage 3 (severe): stupor, flaccidity, small to mid-position pupils with poor light reactivity, reduced stretch reflexes, absent Moro and hypothermia 4. Excluding neonates with significant congenital anomalies.
Animal
Human Disease Modelled
Intervention: Postnatal administration of magnesium sulphate with standard care or as an adjuvant to standard care with therapeutic cooling.
Comparator Control: Placebo control with standard care or as an adjuvant to standard care with therapeutic cooling.
Main Outcome: Composite of death or major long-term neurodevelopmental disability or need for 1 or more anti-convulsant medication reported for studies that have evaluated children 18 months of chronological age or older. Long-term major neurodevelopmental disabilities evaluated include: 1. Cerebral palsy 2. Gross Motor Function Classification System greater than or equal to 3 3. Developmental delay (a score of 2 or more standard deviations below the mean of any standardised infant developmental assessment) 4. Intellectual impairment (intelligence quotient (IQ) of 2 or more standard deviations below the mean) 5. Visual impairment, defined by bilateral visual acuity less than or equal to 6/60 6. Sensorineural hearing impairment, defined by inability to hear sounds less than or equal to 40 decibels Measures of effect Treatment effects for dichotomous outcomes will be reported using summary risk ratio (RR), risk difference (RD), number needed to treat (NNT) or harm (NNH) with 95% confidence intervals (CI). Treatment effects for continuous outcomes will be reported using mean difference (MD) and 95% CIs. Standardised mean difference (SMD) will be used in the event studies assessed the same outcome using different measurements.
Outcome Measure
Additional Outcome: 1. Mortality a. Early (less than or equal to 1 week of age) b. Late (less than or equal to 1 year of age) c. At 18 months or any point during the study 2. Each component of major neurodevelopmental impairment at at 18 months of age or older: a. Cerebral palsy b. Gross Motor Function Classification System greater than or equal to 3 c. Developmental delay, defined by a score of 2 or more standard deviations below the mean of any standardised infant developmental assessment d. Intellectual impairment (intelligence quotient (IQ) of 2 or more standard deviations below the mean) e. Visual impairment, defined by bilateral visual acuity less than or equal to 6/60 f. Sensorineural hearing loss, defined by inability to hear sounds less than or equal to 40 decibels 3. The incidence of adverse effect of magnesium sulphate: a. Heart rate or rhythm abnormalities b. Hypotension or hypertension, including need for inotrope support c. Respiratory rate or oxygen saturation abnormalities d. Electrolyte disturbance (sodium, potassium, calcium, phosphate) 4. Magnetic resonance imaging abnormalities using a validated scoring system 5. Multiorgan dysfunction 6. Use of anti-convulsant medication in the neonatal period Measures of effect Treatment effects for dichotomous outcomes will be reported using summary risk ratio (RR), risk difference (RD), number needed to treat (NNT) or harm (NNH) with 95% confidence intervals (CI). Treatment effects for continuous outcomes will be reported using mean difference (MD) and 95% CIs. Standardised mean difference (SMD) will be used in the event studies assessed the same outcome using different measurements.
Study Method: Intervention, Meta-analysis, Systematic review
Keyword: Humans; Hypoxia-Ischemia, Brain; Infant, Newborn; Magnesium Sulfate
Contact: Gabrielle Jee [email protected]
Organisational Affiliation: Department of Paediatrics, University Hospital of Wales, Cardiff, United Kingdom
Funding Source: No funding was received for this review
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language: English
Country: Wales
Review Stage: Review Ongoing
First Submission Date: 2022-06-11
Registration Date: 2022-06-17
Anticipated Start Date: 2022-06-13
Anticipated Completion Date: 2023-01-31
Title Cn: 硫酸镁治疗新生儿缺氧缺血性脑病
Title En: Magnesium sulphate for neonates with hypoxic ischaemic encephalopathy
Bilingual Status: complete