Late (≥ 7 days) inhalation corticosteroids to reduce bronchopulmonary dysplasia in preterm infants

Wes Onland; Martin Offringa; Anton van Kaam

doi:10.1002/14651858.CD002311.pub4

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Figure 1

Flow of inclusion of randomised controlled trials in different phases of search.

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Figure 2

Study flow diagram: review update.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 1 Combined outcome mortality or bronchopulmonary dysplasia at 36 weeks PMA.

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Analysis 1.2

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 2 Mortality at 28 days PNA.

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Analysis 1.3

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 3 Mortality at 36 weeks PMA.

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Analysis 1.4

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 4 Mortality at hospital discharge.

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Analysis 1.5

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 5 Bronchopulmonary dysplasia at 28 days PNA.

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Analysis 1.6

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 6 Bronchopulmonary dysplasia at 36 weeks PMA.

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Analysis 1.7

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 7 Combined outcome mortality and bronchopulmonary dysplasia at 28 days PNA.

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Analysis 1.8

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 8 Failure to extubate day 7.

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Analysis 1.9

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 9 Failure to extubate day 14.

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Analysis 1.10

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 10 Failure to extubate at the latest reported moment.

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Analysis 1.11

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 11 Days of mechanical ventilation.

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Analysis 1.12

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 12 Days of supplemental oxygen.

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Analysis 1.13

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 13 Open‐label intravenous corticosteroids.

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Analysis 1.14

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 14 Sepsis (clinical suspected or culture proven).

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Analysis 1.15

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 15 Patent ductus arteriosus.

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Analysis 1.16

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 16 Hypertension (> 2 SD).

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Analysis 1.17

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 17 Necrotising enterocolitis.

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Analysis 1.18

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 18 Intraventricular haemorrhage (any grade).

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Analysis 1.19

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 19 Days of hospitalisation.

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Analysis 1.20

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 20 Airway resistance.

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Analysis 1.21

Comparison 1 Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants, Outcome 21 Dynamic lung compliance.

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Summary of findings for the main comparison. Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants

Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants
Patient or population: preterm infants Setting: neonatal intensive care units Intervention: inhaled corticosteroids Comparison: placebo
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with inhaled corticosteroids
Combined outcome mortality or bronchopulmonary dysplasia at 36 weeks postmenstrual age	Study population		RR 1.10 (0.74 to 1.63)	30 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3 4 5}
	533 per 1000	587 per 1000 (395 to 869)
Mortality at 36 weeks postmenstrual age	Study population		RR 3.00 (0.35 to 25.78)	61 (3 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 5 6 7}
	0 per 1000	0 per 1000 (0 to 0)
Bronchopulmonary dysplasia at 36 weeks postmenstrual age	Study population		RR 1.00 (0.59 to 1.70)	30 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{1 2 3 4 5}
	600 per 1000	600 per 1000 (354 to 1000)
Open‐label intravenous corticosteroids	Study population		RR 0.51 (0.26 to 1.00)	74 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 5 8 9 10}
	432 per 1000	320 per 1000 (216 to 476)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
¹Risk of bias: No serious limitations. No downgrade. ²Indirectness: Head‐to‐head comparison. No downgrade. ³Publication bias: Only one trial was able to provide data for this outcome for ventilated and non‐ventilated infants separately. Downgraded one level. ⁴Inconsistency: Difference in effect estimates might be explained by inclusion of both ventilated and non‐ventilated infants. Downgraded one level. ⁵Imprecision: Total number of included infants less than optimal information size calculation. Downgraded one level. ⁶Inconsistency: No inconsistency detected. No downgrade. ⁷Publication bias: Only two of the eight included studies reported this outcome. Downgraded one level. ⁸Inconsistency: Included trials investigated different inhalation drugs. Downgraded one level. ⁹Indirectness: No serious limitations. No downgrade. ¹⁰Publication bias: Funnel plot is asymmetrical. Downgraded one level.

Summary of findings for the main comparison. Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants

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Comparison 1. Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Combined outcome mortality or bronchopulmonary dysplasia at 36 weeks PMA Show forest plot	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.74, 1.63]

1.1 Ventilated infants	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.87, 1.75]
1.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.06, 3.91]
2 Mortality at 28 days PNA Show forest plot	2	51	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.14, 65.90]

2.1 Ventilated infants	2	41	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.14, 65.90]
2.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Mortality at 36 weeks PMA Show forest plot	3	61	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.35, 25.78]

3.1 Ventilated infants	3	51	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.35, 25.78]
3.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Mortality at hospital discharge Show forest plot	3	53	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.35, 25.78]

4.1 Ventilated infants	3	43	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.35, 25.78]
4.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Bronchopulmonary dysplasia at 28 days PNA Show forest plot	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.72, 1.21]

5.1 Ventilated infants	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.61, 1.29]
5.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.71, 1.41]
6 Bronchopulmonary dysplasia at 36 weeks PMA Show forest plot	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.59, 1.70]

6.1 Ventilated infants	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.69, 1.90]
6.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.06, 3.91]
7 Combined outcome mortality and bronchopulmonary dysplasia at 28 days PNA Show forest plot	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.85, 1.18]

7.1 Ventilated infants	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.83, 1.20]
7.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.71, 1.41]
8 Failure to extubate day 7 Show forest plot	5	79	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.66, 0.98]

9 Failure to extubate day 14 Show forest plot	2	27	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.10, 1.33]

10 Failure to extubate at the latest reported moment Show forest plot	6	90	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.45, 0.80]

11 Days of mechanical ventilation Show forest plot	3	45	Mean Difference (IV, Fixed, 95% CI)	3.42 [‐1.30, 8.13]

12 Days of supplemental oxygen Show forest plot	4	141	Mean Difference (IV, Fixed, 95% CI)	0.57 [‐5.92, 7.07]

12.1 Ventilated infants	4	100	Mean Difference (IV, Fixed, 95% CI)	5.53 [‐3.99, 15.05]
12.2 Non‐ventilated infants	2	41	Mean Difference (IV, Fixed, 95% CI)	‐3.74 [‐12.63, 5.14]
13 Open‐label intravenous corticosteroids Show forest plot	4	74	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.26, 1.00]

13.1 Ventilated infants	4	64	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.26, 1.00]
13.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
14 Sepsis (clinical suspected or culture proven) Show forest plot	5	107	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.50, 1.64]

14.1 Ventilated infants	5	97	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.44, 1.77]
14.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.36, 2.75]
15 Patent ductus arteriosus Show forest plot	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.16, 6.20]

15.1 Ventilated infants	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.16, 6.20]
16 Hypertension (> 2 SD) Show forest plot	1	27	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

16.1 Ventilated infants	1	17	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
16.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
17 Necrotising enterocolitis Show forest plot	1	27	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

17.1 Ventilated infants	1	17	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
17.2 Non‐ventilated infants	1	10	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
18 Intraventricular haemorrhage (any grade) Show forest plot	1	19	Risk Ratio (M‐H, Fixed, 95% CI)	0.6 [0.13, 2.82]

18.1 Ventilated infants	1	19	Risk Ratio (M‐H, Fixed, 95% CI)	0.6 [0.13, 2.82]
19 Days of hospitalisation Show forest plot	1	18	Mean Difference (IV, Fixed, 95% CI)	‐24.70 [‐41.75, ‐7.65]

19.1 Ventilated infants	1	18	Mean Difference (IV, Fixed, 95% CI)	‐24.70 [‐41.75, ‐7.65]
20 Airway resistance Show forest plot	1	18	Mean Difference (IV, Fixed, 95% CI)	21.40 [‐71.11, 113.91]

21 Dynamic lung compliance Show forest plot	1	18	Mean Difference (IV, Fixed, 95% CI)	‐0.22 [‐0.33, ‐0.11]

Comparison 1. Inhaled corticosteroids versus placebo to reduce bronchopulmonary dysplasia in preterm infants

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