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Meta-Analysis
. 2017 Jan 4;1(1):CD001969.
doi: 10.1002/14651858.CD001969.pub4.

Early administration of inhaled corticosteroids for preventing chronic lung disease in very low birth weight preterm neonates

Vibhuti S Shah  1 , Arne Ohlsson  2 , Henry L Halliday  3 , Michael Dunn  4
Affiliations
Meta-Analysis

Early administration of inhaled corticosteroids for preventing chronic lung disease in very low birth weight preterm neonates

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

Abstract

Background: Chronic lung disease (CLD) remains a common complication among preterm infants. There is increasing evidence that inflammation plays an important role in the pathogenesis of CLD. Due to their strong anti-inflammatory properties, corticosteroids are an attractive intervention strategy. However, there are growing concerns regarding short- and long-term effects of systemic corticosteroids. Theoretically, administration of inhaled corticosteroids may allow for beneficial effects on the pulmonary system with a lower risk of undesirable systemic side effects.

Objectives: To determine the impact of inhaled corticosteroids administered to preterm infants with birth weight up to 1500 grams (VLBW) beginning in the first two weeks after birth for the prevention of CLD as reflected by the requirement for supplemental oxygen at 36 weeks' postmenstrual age (PMA).

Search methods: Randomised and quasi-randomised trials were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 12) in the Cochrane Library (searched 5 January 2016), MEDLINE (1966 to 5 January 2016), Embase (1980 to 5 January 2016), CINAHL (1982 to 5 January 2016), reference lists of published trials and abstracts published in Pediatric Research or electronically on the Pediatric Academic Societies web-site (1990 to May 2016).

Selection criteria: We included in this review randomised controlled trials of inhaled corticosteroid therapy initiated within the first two weeks of life in VLBW preterm infants.

Data collection and analysis: We evaluated data regarding clinical outcomes, including: CLD at 28 days or 36 weeks' PMA; mortality; combined outcome of death or CLD at 28 days of age and at 36 weeks' PMA; the need for systemic corticosteroids; failure to extubate within 14 days; and adverse effects of corticosteroids. All data were analysed using Review Manager (RevMan) 5. Meta-analyses were performed using relative risk (RR) and risk difference (RD), along with their 95% confidence intervals (CI). If RD was significant, the number needed to treat for an additional beneficial outcome (NNTB) was calculated. We used the GRADE approach to assess the quality of evidence.

Main results: According to GRADE the quality of the studies was moderate. Three additional trials are included in this update. The present review includes data analyses based on 10 qualifying trials that enrolled 1644 neonates. There was no significant difference in the incidence of CLD at 36 weeks' PMA in the inhaled steroid versus the placebo group (5 trials, 429 neonates) among all randomised (typical RR 0.97, 95% CI 0.62 to 1.52; typical RD -0.00, 95% CI -0.07 to 0.06). There was no heterogeneity for this outcome (typical RR I² = 11%; typical RD I² = 0%). There was a significant reduction in the incidence of CLD at 36 weeks' PMA among survivors (6 trials, 1088 neonates) (typical RR 0.76, 95% CI 0.63 to 0.93; typical RD -0.07, 95% CI -0.13 to -0.02; NNTB 14, 95% CI 8 to 50). There was a significant reduction in the combined outcome of death or CLD at 36 weeks' PMA among all randomised neonates (6 trials, 1285 neonates) (typical RR 0.86, 95% CI 0.75 to 0.99; typical RD -0.06, 95% CI -0.11 to -0.00) (P = 0.04); NNTB 17, 95% CI 9 to infinity). There was no significant heterogeneity for any of these analyses (I² = 0%). A lower rate of reintubation was noted in the inhaled steroid group compared with the control group in one study. There were no statistically significant differences in short-term complications between groups and no differences in adverse events at long-term follow-up reported. Long-term follow-up of infants enrolled in the study by Bassler 2015 is ongoing.

Authors' conclusions: Based on this updated review, there is increasing evidence from the trials reviewed that early administration of inhaled steroids to VLBW neonates is effective in reducing the incidence of death or CLD at 36 weeks' PMA among either all randomised infants or among survivors. Even though there is statistical significance, the clinical relevance is of question as the upper CI limit for the outcome of death or CLD at 36 weeks' PMA is infinity. The long-term follow-up results of the Bassler 2015 study may affect the conclusions of this review. Further studies are needed to identify the risk/benefit ratio of different delivery techniques and dosing schedules for the administration of these medications. Studies need to address both the short- and long-term benefits and adverse effects of inhaled steroids with particular attention to neurodevelopmental outcome.

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Conflict of interest statement

Vibhuti Shah: no conflict of interest to declare

Arne Ohlsson: no conflict of interest to declare

Henry Halliday is the co‐author of one included trial (Bassler 2015). He acts as a consultant for Chiesi Farmaceutici, Parma, Italy and is also joint Editor‐in‐Chief of the journal Neonatology.

Michael Dunn: no conflict of interest to declare

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.
4
4
Forest plot of comparison: 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), outcome: 1.1 CLD at 36 weeks' PMA.
5
5
Forest plot of comparison: 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), outcome: 1.6 Death by or CLD at 36 weeks' PMA.
6
6
Forest plot of comparison: 2 Early inhaled steroid (< 2 weeks) vs. placebo (among survivors), outcome: 2.1 CLD at 36 weeks' PMA.
1.1
1.1. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 1 CLD at 36 weeks PMA.
1.2
1.2. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 2 CLD at 28 days of age.
1.3
1.3. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 3 Death by 28 days of age.
1.4
1.4. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 4 Death by 36 weeks PMA.
1.5
1.5. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 5 Death by or CLD at 28 days of age.
1.6
1.6. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 6 Death by or CLD at 36 weeks PMA.
1.7
1.7. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 7 Survival to hospital discharge without CLD.
1.8
1.8. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 8 Death during hospital stay.
1.9
1.9. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 9 Culture proven infection during hospital stay.
1.10
1.10. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 10 Hyperglycaemia.
1.11
1.11. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 11 Hypertension.
1.12
1.12. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 12 Gastrointesinal bleeding.
1.13
1.13. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 13 Cataract.
1.14
1.14. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 14 Intraventricular haemorrhage.
1.15
1.15. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 15 Periventricular leukomalacia.
1.16
1.16. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 16 Brain injury.
1.17
1.17. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 17 Necrotizing enterocolitis.
1.18
1.18. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 18 Retinopathy of prematurity (any stage).
1.19
1.19. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 19 Patent ductus arteriosus.
1.20
1.20. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 20 Reintubation.
1.21
1.21. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 21 Requirement for systemic steroids.
1.22
1.22. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 22 Failure to extubate within 14 days.
1.23
1.23. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 23 Death or oxygen dependency at discharge.
1.24
1.24. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 24 Death or severe BPD.
1.25
1.25. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 25 Death or grade 3 or 4 IVH.
1.26
1.26. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 26 Death or PVL.
1.27
1.27. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 27 Death or NEC.
1.28
1.28. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 28 Death or sepsis.
1.29
1.29. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 29 Death or ROP (stage not stated).
1.30
1.30. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 30 Death or neurodevelopmental impairment at 18 months PMA.
1.31
1.31. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 31 Death or neurodevelopmental impairment at 3 years of age.
1.32
1.32. Analysis
Comparison 1 Early inhaled steroids (< 2 weeks) vs. placebo (among all randomised), Outcome 32 Death or cerebral palsy at 3 years of age.
2.1
2.1. Analysis
Comparison 2 Early inhaled steroid (< 2 weeks) vs. placebo (among survivors), Outcome 1 CLD at 36 weeks PMA.
2.2
2.2. Analysis
Comparison 2 Early inhaled steroid (< 2 weeks) vs. placebo (among survivors), Outcome 2 CLD at 28 days of age.
2.3
2.3. Analysis
Comparison 2 Early inhaled steroid (< 2 weeks) vs. placebo (among survivors), Outcome 3 Cerebral palsy.
2.4
2.4. Analysis
Comparison 2 Early inhaled steroid (< 2 weeks) vs. placebo (among survivors), Outcome 4 Mean developmental index on BSID‐II < 2 SD of the mean.
2.5
2.5. Analysis
Comparison 2 Early inhaled steroid (< 2 weeks) vs. placebo (among survivors), Outcome 5 Respiratory readmission.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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References to other published versions of this review

Shah 2000
    1. Shah V, Ohlsson A, Halliday HL, Dunn MS. Early administration of inhaled corticosteroids for preventing chronic lung disease in ventilated very low birth weight preterm neonates. Cochrane Database of Systematic Reviews 2000, Issue 1. [DOI: 10.1002/14651858.CD001969] - DOI - PubMed
Shah 2007
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