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Meta-Analysis
. 2017 Oct 17;10(10):CD002058.
doi: 10.1002/14651858.CD002058.pub3.

Inhaled versus systemic corticosteroids for preventing bronchopulmonary dysplasia in ventilated very low birth weight preterm neonates

Sachin S Shah  1 , Arne Ohlsson, Henry L Halliday, Vibhuti S Shah
Affiliations
Meta-Analysis

Inhaled versus systemic corticosteroids for preventing bronchopulmonary dysplasia in ventilated very low birth weight preterm neonates

Sachin S Shah et al. Cochrane Database Syst Rev. .

Abstract

Background: Bronchopulmonary dysplasia (BPD) remains an important cause of mortality and morbidity in preterm infants and inflammation plays a significant role in its pathogenesis. The use of inhaled corticosteroids may modulate the inflammatory process without concomitant high systemic steroid concentrations and less risk of adverse effects. This is an update of a review published in 2012 (Shah 2012). We recently updated the related review on "Inhaled versus systemic corticosteroids for treating bronchopulmonary dysplasia in ventilated very low birth weight preterm neonates".

Objectives: To determine the effect of inhaled versus systemic corticosteroids started within the first 7 days of life on preventing death or BPD in ventilated very low birth weight infants.

Search methods: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 1), MEDLINE via PubMed (1966 to 23 February 2017), Embase (1980 to 23 February 2017), and CINAHL (1982 to 23 February 2017). We searched clinical trials registers, conference proceedings and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.

Selection criteria: Randomised or quasi-randomised controlled trials comparing inhaled versus systemic corticosteroid therapy (irrespective of dose and duration) starting in the first seven days of life in very low birth weight preterm infants receiving assisted ventilation.

Data collection and analysis: Clinical outcomes data were extracted and analysed using Review Manager. When appropriate, meta-analysis was performed using typical relative risk (RR), typical risk difference (RD) and weighted mean difference (WMD). Meta-analyses were performed using typical relative risk, typical risk difference (RD), and weighted mean difference with their 95% confidence intervals (CI). If RD was statistically significant, the number needed to benefit or the number needed to harm was calculated. We assessed the quality of evidence was evaluated using GRADE principles.

Main results: We included two trials that involved 294 infants. No new studies were included for the 2017 update. The incidence of death or BPD at 36 weeks' postmenstrual age was not statistically significantly different between infants who received inhaled or systemic steroids (RR 1.09, 95% CI 0.88 to 1.35; RD 0.05, 95% CI -0.07 to 0.16; 1 trial, N = 278). The incidence of BPD at 36 weeks' postmenstrual age among survivors was not statistically significant between groups (RR 1.34, 95% CI 0.94 to 1.90; RD 0.11, 95% CI -0.02 to 0.24; 1 trial, N = 206). There was no statistically significant difference in the outcomes of BPD at 28 days, death at 28 days or 36 weeks' postmenstrual age and the combined outcome of death or BPD by 28 days between groups (2 trials, N = 294). The duration of mechanical ventilation was significantly longer in the inhaled steroid group compared with the systemic steroid group (typical MD 4 days, 95% CI 0.2 to 8; 2 trials, N = 294; I² = 0%) as was the duration of supplemental oxygen (typical MD 11 days, 95% CI 2 to 20; 2 trials, N = 294; I² = 33%).The incidence of hyperglycaemia was significantly lower with inhaled steroids (RR 0.52, 95% CI 0.39 to 0.71; RD -0.25, 95% CI -0.37 to -0.14; 1 trial, N = 278; NNTB 4, 95% CI 3 to 7 to avoid 1 infant experiencing hyperglycaemia). The rate of patent ductus arteriosus increased in the group receiving inhaled steroids (RR 1.64, 95% CI 1.23 to 2.17; RD 0.21, 95% CI 0.10 to 0.33; 1 trial, N = 278; NNTH 5, 95% CI 3 to 10). In a subset of surviving infants in the United Kingdom and Ireland there were no significant differences in developmental outcomes at 7 years of age. However, there was a reduced risk of having ever been diagnosed as asthmatic by 7 years of age in the inhaled steroid group compared with the systemic steroid group (N = 48) (RR 0.42, 95% CI 0.19 to 0.94; RD -0.31, 95% CI -0.58 to -0.05; NNTB 3, 95% CI 2 to 20).According to GRADE the quality of the evidence was moderate to low. Evidence was downgraded on the basis of design (risk of bias), consistency (heterogeneity) and precision of the estimates.Both studies received grant support and the industry provided aero chambers and metered dose inhalers of budesonide and placebo for the larger study. No conflict of interest was identified.

Authors' conclusions: We found no evidence that early inhaled steroids confer important advantages over systemic steroids in the management of ventilator-dependent preterm infants. Based on this review inhaled steroids cannot be recommended over systemic steroids as a part of standard practice for ventilated preterm infants. Because they might have fewer adverse effects than systemic steroids, further randomised controlled trials of inhaled steroids are needed that address risk/benefit ratio of different delivery techniques, dosing schedules and long-term effects, with particular attention to neurodevelopmental outcome.

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Conflict of interest statement

Dr Sachin S Shah has no conflict of interest to declare.

Dr Arne Ohlsson has no conflict of interest to declare.

Dr Henry L Halliday is the first author of an included trial (Halliday 2001a).

Dr. Vibhuti S Shah has no conflict of interest to declare.

Figures

1
1
Study flow diagram: review update
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 Inhaled versus systemic steroids among all randomised, Outcome 1 Death or BPD at 36 weeks' postmenstrual age.
1.2
1.2. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 2 BPD at 36 weeks' postmenstrual age.
1.3
1.3. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 3 Death at 36 weeks' postmenstrual age.
1.4
1.4. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 4 Death or BPD at 28 days.
1.5
1.5. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 5 BPD at 28 days.
1.6
1.6. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 6 Death at 28 days.
1.7
1.7. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 7 Duration of mechanical ventilation (days).
1.8
1.8. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 8 Duration of supplemental oxygen (days).
1.9
1.9. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 9 Hyperglycaemia.
1.10
1.10. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 10 Patent ductus arteriosus.
1.11
1.11. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 11 Gastrointestinal haemorrhage.
1.12
1.12. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 12 Gastrointestinal perforation.
1.13
1.13. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 13 Infants with detectable free elastase (inflammatory mediator) in tracheal aspirate fluid on day 14.
1.14
1.14. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 14 Pneumothorax.
1.15
1.15. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 15 Other air leaks.
1.16
1.16. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 16 Pulmonary haemorrhage.
1.17
1.17. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 17 Hypertension.
1.18
1.18. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 18 Necrotising enterocolitis.
1.19
1.19. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 19 Retinopathy of prematurity ‐ any stage.
1.20
1.20. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 20 Retinopathy of prematurity ≥ stage 3.
1.21
1.21. Analysis
Comparison 1 Inhaled versus systemic steroids among all randomised, Outcome 21 Sepsis.
2.1
2.1. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 1 BPD at 36 weeks' postmenstrual age.
2.2
2.2. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 2 BPD at 28 days.
2.3
2.3. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 3 General conceptual ability (GCA) score at 7 years.
2.4
2.4. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 4 Child Behaviour Checklist at 7 years.
2.5
2.5. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 5 Strengths and Difficulties Questionnaire at 7 years.
2.6
2.6. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 6 Cerebral palsy at 7 years.
2.7
2.7. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 7 Moderate/severe disability at 7 years.
2.8
2.8. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 8 Death or moderate/severe disability at 7 years.
2.9
2.9. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 9 Systolic blood pressure > 95th percentile at 7 years.
2.10
2.10. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 10 Diastolic blood pressure > 95th percentile at 7 years.
2.11
2.11. Analysis
Comparison 2 Inhaled versus systemic steroids among survivors, Outcome 11 Ever diagnosed as asthmatic at 7 years.
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Update of

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References to other published versions of this review

Shah 2003
    1. Shah SS, Ohlsson A, Halliday H, Shah VS. Inhaled versus systemic corticosteroids for preventing chronic lung disease in ventilated very low birth weight preterm neonates. Cochrane Database of Systematic Reviews 2003, Issue 1. [DOI: 10.1002/14651858.CD002058] - DOI - PubMed
Shah 2012
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