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. 2023 Oct 9;10(10):CD013232.
doi: 10.1002/14651858.CD013232.pub2.

Superoxide dismutase for bronchopulmonary dysplasia in preterm infants

Martina Albertella  1 , Rahul R Gentyala  2 , Themistoklis Paraskevas  3 , Danielle Ehret  4 , Matteo Bruschettini  5   6 , Roger Soll  4
Affiliations

Superoxide dismutase for bronchopulmonary dysplasia in preterm infants

Martina Albertella et al. Cochrane Database Syst Rev. .

Abstract

Background: Free oxygen radicals have been implicated in the pathogenesis of bronchopulmonary dysplasia (BPD) in preterm infants. Superoxide dismutase (SOD) is a naturally occurring enzyme which provides a defense against such oxidant injury. Providing supplementary SOD has been tested in clinical trials to prevent BPD in preterm infants.

Objectives: To determine the efficacy and safety of SOD in the prevention and treatment of BPD on mortality and other complications of prematurity in infants at risk for, or having BPD.

Search methods: We searched CENTRAL, PubMed, Embase, and three trials registers on 22 September 2022 together with reference checking, citation searching and contact with study authors to identify additional studies.

Selection criteria: Randomized, quasi-randomized and cluster-randomized controlled trials (RCTs) where the participants were preterm infants who had developed, or were at risk of developing BPD, and who were randomly allocated to receive either SOD (in any form, by any route, any dose, anytime) or placebo, or no treatment.

Data collection and analysis: We used standard Cochrane methods. Our primary outcomes were BPD defined as an oxygen requirement at 28 days, BPD defined as oxygen at 36 weeks' postmenstrual age, neonatal mortality, mortality prior to discharge, and BPD or death at 36 weeks' postmenstrual age. We reported risk ratio (RR) and risk difference (RD) with 95% confidence intervals (CIs) for the dichotomous outcomes. We used GRADE to assess certainty of evidence for each outcome.

Main results: We included three RCTs (380 infants) on SOD administration in preterm infants at risk for BPD, and no studies in preterm infants with evolving BPD / early respiratory insufficiency. The evidence is very uncertain about the effect of SOD on BPD defined as an oxygen requirement at 28 days (RR 1.09, 95% CI 0.94 to 1.26; RD 0.06, 95% CI -0.05 to 0.16, 1 study, 302 infants; I2 for RR and RD not applicable), BPD defined as oxygen at 36 weeks' postmenstrual age (RR 0.96, 95% CI 0.72 to 1.29; RD -0.01, 95% CI -0.11 to 0.09, 2 studies, 335 infants; I2 for RR and RD = 0%), neonatal mortality (RR 0.98, 95% CI 0.57 to 1.68; RD -0.00, 95% CI -0.08 to 0.07, 2 studies, 335 infants; I2 for RR and RD = 0%), and mortality prior to discharge (RR 1.20, 95% CI 0.53 to 2.71; RD 0.04, 95% CI -0.14 to 0.23, 2 studies, 78 infants; I2 for RR and RD = 0%). No studies reported BPD or death at 36 weeks' postmenstrual age. The evidence is very uncertain about the effect of SOD on retinopathy of prematurity any stage (RR 0.95, 95% CI 0.78 to 1.15; RD -0.03, 95% CI -0.15 to 0.08, 2 studies, 335 infants; I2for RR = 0%, I2 for RD = 8%), and severe retinopathy of prematurity (ROP) (RR 0.97, 95% CI 0.57 to 1.65; RD -0.01, 95% CI -0.10 to 0.09, 1 study, 244 infants; I2 for RR and RD not applicable). No studies reported moderate to severe neurodevelopmental outcome at 18 to 24 months. Certainty of evidence was very low for all outcomes. We identified no ongoing trials.

Authors' conclusions: The evidence is very uncertain about the effect of SOD on BPD defined as an oxygen requirement at 28 days, BPD defined as oxygen at 36 weeks' postmenstrual age, neonatal mortality and mortality prior to discharge compared to placebo. No studies reported BPD or death at 36 weeks' postmenstrual age and need for supplemental oxygen. The evidence is very uncertain about the effect of SOD on retinopathy of prematurity any stage and severe retinopathy of prematurity. No studies reported moderate to severe neurodevelopmental outcome at 18 to 24 months. The effects of SOD in preterm infants has not been reported in any trial in the last few decades, considering that the most recent trial on SOD in preterm infants was conducted in 1997/1998, and no new studies are ongoing. In the light of the limited available evidence, new data from preclinical and observational studies are needed to justify the conduction of new RCTs. Observational studies might report how SOD is administered, including indication, dose and association with relevant outcomes such as mortality, BPD and long-term neurodevelopment.

PubMed Disclaimer

Conflict of interest statement

MA has no relevant interests to declare.

RRG has no relevant interests to declare.

TP has no relevant interests to declare.

DE is an Associate editor of Cochrane Neonatal Review Group. However, her participation in the editorial group has not impacted this review.

MB is an Associate Editor for the Cochrane Neonatal Group. However, his participation in the editorial group has not impacted this review.

RS is the Co‐ordinating Editor of Cochrane Neonatal (therefore the review was seen and edited by other members of the editorial team).

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 1: BPD defined as an oxygen requirement at 28 days
1.2
1.2. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 2: BPD defined as oxygen at 36 weeks' postmenstrual age
1.3
1.3. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 3: Neonatal Mortality
1.4
1.4. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 4: Mortality prior to discharge
1.5
1.5. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 5: Hemodynamically significant patent ductus arteriosus
1.6
1.6. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 6: Late onset sepsis (with proven culture)
1.7
1.7. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 7: Necrotizing enterocolitis
1.8
1.8. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 8: Intraventricular hemorrhage (any grade)
1.9
1.9. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 9: Severe Intraventricular hemorrhage (Grades III / IV)
1.10
1.10. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 10: Periventricular leukomalacia (PVL)
1.11
1.11. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 11: Retinopathy of prematurity (any stage)
1.12
1.12. Analysis
Comparison 1: Superoxide dismutase versus placebo, Outcome 12: Severe retinopathy of prematurity (stage II or greater)
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD013232

References

References to studies included in this review

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