Inhaled nitric oxide for respiratory failure in preterm infants

Keith J Barrington; Neil Finer; Thomas Pennaforte

doi:10.1002/14651858.CD000509.pub5

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Figure 1

Study flow diagram: review update.

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Figure 2

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

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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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Analysis 1.1

Comparison 1 Inhaled NO compared with control, Outcome 1 Death before discharge.

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Analysis 1.2

Comparison 1 Inhaled NO compared with control, Outcome 2 Death before 36 weeks' postmenstrual age.

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Analysis 1.3

Comparison 1 Inhaled NO compared with control, Outcome 3 Bronchopulmonary dysplasia among survivors at 36 weeks.

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Analysis 1.4

Comparison 1 Inhaled NO compared with control, Outcome 4 Death or bronchopulmonary dysplasia at 36 weeks.

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Analysis 1.5

Comparison 1 Inhaled NO compared with control, Outcome 5 Intraventricular haemorrhage (all grades).

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Analysis 1.6

Comparison 1 Inhaled NO compared with control, Outcome 6 Intraventricular haemorrhage (grade 3 or 4).

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Analysis 1.7

Comparison 1 Inhaled NO compared with control, Outcome 7 Intraventricular haemorrhage (grade 3 or 4) or periventricular leukomalacia.

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Analysis 1.8

Comparison 1 Inhaled NO compared with control, Outcome 8 Neurodevelopmental disability.

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Analysis 1.9

Comparison 1 Inhaled NO compared with control, Outcome 9 Bayley MDI or PDI < ‐2 SD.

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Analysis 1.10

Comparison 1 Inhaled NO compared with control, Outcome 10 Cerebral palsy.

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Analysis 1.11

Comparison 1 Inhaled NO compared with control, Outcome 11 Severe retinopathy of prematurity (≥stage 3).

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Analysis 1.12

Comparison 1 Inhaled NO compared with control, Outcome 12 Retinopathy of prematurity requiring surgery.

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Summary of findings for the main comparison. Inhaled NO compared with control for respiratory failure in preterm infants

Inhaled NO compared with control for respiratory failure in preterm infants
Patient or population: respiratory failure in preterm infants Setting: neonatal intensive care units Intervention: inhaled NO Comparison: placebo or no treatment
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo or no treatment	Risk with Inhaled NO
Death before discharge ‐ Studies with entry before 3 days based on oxygenation	Study population		RR 1.02 (0.89 to 1.18)	1066 (10 RCTs)	⊕⊕⊕⊕ High
	394 per 1000	402 per 1000 (351 to 465)
Death before discharge ‐ Studies with entry after 3 days based on BPD risk	Study population		RR 1.18 (0.81 to 1.71)	1075 (3 RCTs)	⊕⊕⊕⊕ High
	83 per 1000	98 per 1000 (67 to 141)
Death before discharge ‐ Studies of routine use in preterm infants on respiratory support	Study population		RR 0.90 (0.74 to 1.10)	1924 (4 RCTs)	⊕⊕⊕⊝ Moderate^a
	170 per 1000	153 per 1000 (126 to 187)
Death or bronchopulmonary dysplasia at 36 weeks ‐ Studies with entry before 3 days based on oxygenation	Study population		RR 0.94 (0.87 to 1.01)	958 (8 RCTs)	⊕⊕⊕⊕ High
	743 per 1000	698 per 1000 (646 to 750)
Death or bronchopulmonary dysplasia at 36 weeks ‐ Studies with entry after 3 days based on BPD risk	Study population		RR 0.92 (0.85 to 1.01)	1075 (3 RCTs)	⊕⊕⊕⊕ High
	667 per 1000	614 per 1000 (567 to 674)
Death or bronchopulmonary dysplasia at 36 weeks ‐ Studies of routine use in preterm infants on respiratory support	Study population		RR 0.94 (0.87 to 1.02)	1924 (4 RCTs)	⊕⊕⊕⊕ High
	548 per 1000	515 per 1000 (477 to 559)
Intraventricular haemorrhage (grade 3 or 4) ‐ Studies with entry before 3 days based on oxygenation	Study population		RR 1.20 (0.98 to 1.47)	773 (6 RCTs)	⊕⊕⊕⊕ High
	231 per 1000	278 per 1000 (227 to 340)
Intraventricular haemorrhage (grade 3 or 4) ‐ Studies of routine use in preterm infants on respiratory support	Study population		RR 0.89 (0.73 to 1.09)	1913 (4 RCTs)	⊕⊕⊕⊝ Moderate^b
	127 per 1000	113 per 1000 (93 to 139)
Neurodevelopmental disability ‐ Studies with entry before 3 days based on oxygenation	Study population		RR 1.05 (0.78 to 1.40)	208 (2 RCTs)	⊕⊕⊕⊝ Moderate^c
	455 per 1000	477 per 1000 (355 to 636)
Neurodevelopmental disability ‐ Studies with entry after 3 days based on BPD risk	Study population		RR 0.90 (0.74 to 1.09)	498 (2 RCTs)	⊕⊕⊕⊝ Moderate^c
	480 per 1000	432 per 1000 (355 to 523)
Neurodevelopmental disability ‐ Studies of routine use in preterm infants on respiratory support	Study population		RR 0.91 (0.74 to 1.13)	1223 (3 RCTs)	⊕⊕⊕⊕ High
	195 per 1000	178 per 1000 (144 to 220)
*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and relative effect of the intervention (and its 95% CI). CI: confidence interval; OR: odds ratio; 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 effect. Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different. Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of 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.
^aHighly variable risk ratio in individual trials (I² = 50%). ^bHighly variable risk ratio in individual trials (I² = 33%). ^cBased on 2 studies, wide confidence intervals.

Summary of findings for the main comparison. Inhaled NO compared with control for respiratory failure in preterm infants

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Comparison 1. Inhaled NO compared with control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death before discharge Show forest plot	17		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Studies with entry before 3 days based on oxygenation	10	1066	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.89, 1.18]
1.2 Studies with entry after 3 days based on BPD risk	3	1075	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.81, 1.71]
1.3 Studies of routine use in preterm infants on respiratory support	4	1924	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.74, 1.10]
2 Death before 36 weeks' postmenstrual age Show forest plot	9		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 Studies with entry before 3 days based on oxygenation	5	458	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.72, 1.11]
2.2 Studies with entry after 3 days based on BPD risk	2	493	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.81, 2.20]
2.3 Studies of routine use in preterm infants on respiratory support	2	924	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [0.90, 1.89]
3 Bronchopulmonary dysplasia among survivors at 36 weeks Show forest plot	15		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 Studies with entry before 3 days based on oxygenation	8	681	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.76, 1.04]
3.2 Studies with entry after 3 days based on BPD risk	3	990	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.83, 1.01]
3.3 Studies of routine use in preterm infants on respiratory support	4	1782	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.85, 1.05]
4 Death or bronchopulmonary dysplasia at 36 weeks Show forest plot	15		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 Studies with entry before 3 days based on oxygenation	8	958	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.87, 1.01]
4.2 Studies with entry after 3 days based on BPD risk	3	1075	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.85, 1.01]
4.3 Studies of routine use in preterm infants on respiratory support	4	1924	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.87, 1.02]
5 Intraventricular haemorrhage (all grades) Show forest plot	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 Studies with entry before 3 days based on oxygenation	4	314	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.69, 1.28]
5.2 Studies with entry after 3 days based on BPD risk	1	458	Risk Ratio (M‐H, Fixed, 95% CI)	1.1 [0.48, 2.54]
5.3 Studies of routine use in preterm infants on respiratory support	2	1573	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.88, 1.23]
6 Intraventricular haemorrhage (grade 3 or 4) Show forest plot	10		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 Studies with entry before 3 days based on oxygenation	6	773	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.98, 1.47]
6.2 Studies of routine use in preterm infants on respiratory support	4	1913	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.73, 1.09]
7 Intraventricular haemorrhage (grade 3 or 4) or periventricular leukomalacia Show forest plot	11		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 Studies with entry before 3 days based on oxygenation	8	901	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.88, 1.33]
7.2 Studies of routine use in preterm infants on respiratory support	3	1747	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.73, 1.12]
8 Neurodevelopmental disability Show forest plot	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 Studies with entry before 3 days based on oxygenation	2	208	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.78, 1.40]
8.2 Studies with entry after 3 days based on BPD risk	2	498	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.74, 1.09]
8.3 Studies of routine use in preterm infants on respiratory support	3	1223	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.74, 1.13]
9 Bayley MDI or PDI < ‐2 SD Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 Studies of routine use in preterm infants on respiratory support	2	768	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.36, 0.90]
10 Cerebral palsy Show forest plot	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 Studies with entry before 3 days based on oxygenation	2	209	Risk Ratio (M‐H, Fixed, 95% CI)	1.85 [0.93, 3.71]
10.2 Studies with entry after 3 days based on BPD risk	2	498	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.54, 2.23]
10.3 Studies of routine use in preterm infants on respiratory support	3	1223	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.69, 1.47]
11 Severe retinopathy of prematurity (≥stage 3) Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 Studies with entry before 3 days based on oxygenation	3	261	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.64, 1.47]
11.2 Studies of routine use in preterm infants on respiratory support	2	331	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.29, 1.46]
12 Retinopathy of prematurity requiring surgery Show forest plot	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

12.1 Studies with entry before 3 days based on oxygenation	4	673	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.59, 1.29]
12.2 Studies with entry after 3 days based on BPD risk	1	582	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.78, 1.38]
12.3 Studies of routine use in preterm infants on respiratory support	2	917	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.79, 1.47]

Comparison 1. Inhaled NO compared with control

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