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Study flow diagram: review update.
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Figure 1

Study flow diagram: review update.

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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 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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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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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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Comparison 1 Sildenafil versus placebo, Outcome 1 Pulmonary arterial pressure.
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Analysis 1.1

Comparison 1 Sildenafil versus placebo, Outcome 1 Pulmonary arterial pressure.

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Comparison 1 Sildenafil versus placebo, Outcome 2 PaO2 in mmHg (absolute values).
Figuras y tablas -
Analysis 1.2

Comparison 1 Sildenafil versus placebo, Outcome 2 PaO2 in mmHg (absolute values).

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Comparison 1 Sildenafil versus placebo, Outcome 3 Mean arterial blood pressure in mmHg.
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Analysis 1.3

Comparison 1 Sildenafil versus placebo, Outcome 3 Mean arterial blood pressure in mmHg.

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Comparison 1 Sildenafil versus placebo, Outcome 4 All‐cause mortality.
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Analysis 1.4

Comparison 1 Sildenafil versus placebo, Outcome 4 All‐cause mortality.

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Comparison 1 Sildenafil versus placebo, Outcome 5 Oxygenation index (absolute values).
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Analysis 1.5

Comparison 1 Sildenafil versus placebo, Outcome 5 Oxygenation index (absolute values).

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Comparison 1 Sildenafil versus placebo, Outcome 6 Change in oxygenation index.
Figuras y tablas -
Analysis 1.6

Comparison 1 Sildenafil versus placebo, Outcome 6 Change in oxygenation index.

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Comparison 1 Sildenafil versus placebo, Outcome 7 A‐a DO2 difference.
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Analysis 1.7

Comparison 1 Sildenafil versus placebo, Outcome 7 A‐a DO2 difference.

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Comparison 1 Sildenafil versus placebo, Outcome 8 Mean airway pressure.
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Analysis 1.8

Comparison 1 Sildenafil versus placebo, Outcome 8 Mean airway pressure.

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Comparison 2 Sildenafil versus active control, Outcome 1 All‐cause mortality.
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Analysis 2.1

Comparison 2 Sildenafil versus active control, Outcome 1 All‐cause mortality.

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Comparison 2 Sildenafil versus active control, Outcome 2 Time to adequate response (days).
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Analysis 2.2

Comparison 2 Sildenafil versus active control, Outcome 2 Time to adequate response (days).

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Comparison 2 Sildenafil versus active control, Outcome 3 Duration of ventilation (days).
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Analysis 2.3

Comparison 2 Sildenafil versus active control, Outcome 3 Duration of ventilation (days).

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Comparison 2 Sildenafil versus active control, Outcome 4 Inotropic agent.
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Analysis 2.4

Comparison 2 Sildenafil versus active control, Outcome 4 Inotropic agent.

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Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 1 All‐cause mortality.
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Analysis 3.1

Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 1 All‐cause mortality.

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Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 2 Length of stay in hospital (days).
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Analysis 3.2

Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 2 Length of stay in hospital (days).

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Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 3 Inotropic agent.
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Analysis 3.3

Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 3 Inotropic agent.

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Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 4 Duration of ventilation (days).
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Analysis 3.4

Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 4 Duration of ventilation (days).

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Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 5 Retinopathy of prematurity.
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Analysis 3.5

Comparison 3 Sildenafil plus iNO versus placebo plus iNO, Outcome 5 Retinopathy of prematurity.

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Summary of findings for the main comparison. Sildenafil compared with placebo for pulmonary hypertension in neonates

Sildenafil compared with placebo for pulmonary hypertension in neonates

Patient or population: pulmonary hypertension in neonates
Setting: neonatal intensive care unit
Intervention: sildenafil
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with sildenafil

PaO2 in mmHg (absolute values) After 24‐25 hours

Mean PaO2 in mmHg (absolute values)
After 24 to 25 hours = 0

MD 15.31 higher
(6.49 higher to 24.13 higher)

‐

57
(2 RCTs)

⊕⊕⊝⊝
LOWa,b

Evidence was downgraded due to unreported methodological features and imprecision (small sample size)

Change in oxygenation index
After 24 hours of treatment

Mean change in oxygenation index
After 24 hours = 0

MD 38.79 lower
(56.97 lower to 20.61 lower)

‐

12
(1 RCT)

⊕⊕⊝⊝
LOWa,b

Evidence was downgraded due to unreported methodological features and imprecision (small sample size)

All‐cause mortality

Study population

RR 0.20
(0.07 to 0.56)

77
(3 RCTs)

⊕⊕⊝⊝
LOWa,b

Evidence was downgraded due to unreported methodological features and imprecision (small sample size)

432 per 1000

77 per 1000
(22 to 238)

*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; MD: mean difference; 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

aImprecise due to small sample size

bRisk of bias due to unclear randomisation allocation and lack of clinical trial registration

Figuras y tablas -
Summary of findings for the main comparison. Sildenafil compared with placebo for pulmonary hypertension in neonates
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Summary of findings 2. Sildenafil compared with active control for pulmonary hypertension in neonates

Sildenafil compared with active control for pulmonary hypertension in neonates

Patient or population: pulmonary hypertension in neonates
Setting: neonatal intensive care unit
Intervention: sildenafil
Comparison: magnesium sulphate

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with magnesium sulphate

Risk with sildenafil

All‐cause mortality

Study population

RR 0.55
(0.05 to 5.75)

65
(1 RCT)

⊕⊝⊝⊝
VERY LOWa,b

Evidence was downgraded due to very serious imprecision, as results from this single study have not been replicated and risk of bias is evident in study design (missing data)

59 per 1000

32 per 1000
(3 to 338)

*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; MD: mean difference; 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

aImprecise due to small sample size; only one included study

bRisk of bias due to missing data (not analysed as intent to treat)

Figuras y tablas -
Summary of findings 2. Sildenafil compared with active control for pulmonary hypertension in neonates
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Summary of findings 3. Sildenafil plus iNO compared with placebo plus iNO for pulmonary hypertension in neonates

Sildenafil plus iNO compared with placebo plus iNO for pulmonary hypertension in neonates

Patient or population: pulmonary hypertension in neonates
Setting: neonatal intensive care unit
Intervention: sildenafil plus iNO
Comparison: placebo plus iNO

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo plus iNO

Risk with sildenafil plus iNO

All‐cause mortality

Study population

RR 1.27
(0.26 to 6.28)

24
(1 RCT)

⊕⊕⊝⊝
LOWa

Evidence was downgraded due to imprecision .

182 per 1000

231 per 1000
(38 to 690)

Length of stay in hospital (days)

Mean length of stay in hospital was 17.81 days.

MD 5.39 higher
(5.31 lower to 16.09 higher)

‐

24
(1 RCT)

⊕⊕⊝⊝
LOWa

Evidence was downgraded due to imprecision .

*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; MD: mean difference; 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

aImprecise due to very small sample size; only one included study

Figuras y tablas -
Summary of findings 3. Sildenafil plus iNO compared with placebo plus iNO for pulmonary hypertension in neonates
Ir a la tabla de la revisión
Comparison 1. Sildenafil versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pulmonary arterial pressure Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1.1 Baseline

1

40

Mean Difference (IV, Fixed, 95% CI)

1.10 [‐7.68, 9.88]

2 PaO2 in mmHg (absolute values) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

2.1 At baseline

2

64

Mean Difference (IV, Fixed, 95% CI)

8.06 [1.58, 14.54]

2.2 After first dose

2

64

Mean Difference (IV, Fixed, 95% CI)

11.09 [1.65, 20.52]

2.3 After 6 to 7 hours of treatment

2

64

Mean Difference (IV, Fixed, 95% CI)

14.30 [5.25, 23.34]

2.4 After 24 to 25 hours of treatment

2

58

Mean Difference (IV, Fixed, 95% CI)

15.31 [6.49, 24.13]

2.5 After 72 hours or at the end of treatment

1

24

Mean Difference (IV, Fixed, 95% CI)

20.98 [14.81, 27.15]

3 Mean arterial blood pressure in mmHg Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 Before initiation of therapy

2

53

Mean Difference (IV, Fixed, 95% CI)

5.65 [2.69, 8.61]

3.2 At the end of therapy

2

40

Mean Difference (IV, Fixed, 95% CI)

22.70 [1.23, 44.17]

4 All‐cause mortality Show forest plot

3

77

Risk Difference (M‐H, Fixed, 95% CI)

‐0.36 [‐0.53, ‐0.18]

5 Oxygenation index (absolute values) Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

5.1 At baseline

3

77

Mean Difference (IV, Fixed, 95% CI)

‐0.74 [‐8.11, 6.64]

5.2 After first dose

3

77

Mean Difference (IV, Fixed, 95% CI)

‐12.53 [‐18.60, ‐6.47]

5.3 After 6 to 7 hours of treatment

2

75

Mean Difference (IV, Fixed, 95% CI)

‐20.07 [‐26.12, ‐14.02]

5.4 After 24 to 25 hours of treatment

3

69

Mean Difference (IV, Fixed, 95% CI)

‐19.15 [‐24.52, ‐13.77]

5.5 After 30 hours of treatment

1

11

Mean Difference (IV, Fixed, 95% CI)

‐45.46 [‐61.87, ‐29.05]

5.6 After 36 hours of treatment

1

8

Mean Difference (IV, Fixed, 95% CI)

‐31.75 [‐45.74, ‐17.76]

5.7 After 72 hours or at the end of treatment

1

24

Mean Difference (IV, Fixed, 95% CI)

‐19.47 [‐23.42, ‐15.52]

6 Change in oxygenation index Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

6.1 After first dose

1

13

Mean Difference (IV, Fixed, 95% CI)

‐17.14 [‐27.75, ‐6.53]

6.2 After 24 hours of treatment

1

12

Mean Difference (IV, Fixed, 95% CI)

‐38.79 [‐56.97, ‐20.61]

6.3 After 30 hours of treatment

1

11

Mean Difference (IV, Fixed, 95% CI)

‐33.08 [‐50.85, ‐15.31]

6.4 After 36 hours of treatment

1

8

Mean Difference (IV, Fixed, 95% CI)

‐44.75 [‐65.55, ‐23.95]

7 A‐a DO2 difference Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

7.1 Baseline

2

64

Mean Difference (IV, Fixed, 95% CI)

0.99 [‐11.54, 13.51]

7.2 At 6 to 7 hours of treatment

1

24

Mean Difference (IV, Fixed, 95% CI)

0.01 [‐27.72, 27.74]

7.3 At 24 to 25 hours of treament

2

57

Mean Difference (IV, Fixed, 95% CI)

1.59 [‐18.98, 22.16]

7.4 At 72 hours or at the end of treatment

1

24

Mean Difference (IV, Fixed, 95% CI)

‐18.34 [‐26.59, ‐10.09]

8 Mean airway pressure Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

8.1 Baseline

2

64

Mean Difference (IV, Fixed, 95% CI)

‐2.09 [‐3.30, ‐0.88]

8.2 At 6 to 7 hours of treatment

2

63

Mean Difference (IV, Fixed, 95% CI)

‐5.94 [‐7.36, ‐4.52]

8.3 At 24 to 25 hours of treatment

2

57

Mean Difference (IV, Fixed, 95% CI)

‐6.64 [‐8.49, ‐4.80]

8.4 At 72 hours or at the end of treatment

1

24

Mean Difference (IV, Fixed, 95% CI)

‐8.58 [‐10.37, ‐6.79]
Figuras y tablas -
Comparison 1. Sildenafil versus placebo
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Comparison 2. Sildenafil versus active control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All‐cause mortality Show forest plot

1

65

Risk Difference (M‐H, Fixed, 95% CI)

‐0.03 [‐0.13, 0.07]

2 Time to adequate response (days) Show forest plot

1

65

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐4.20, 3.00]

3 Duration of ventilation (days) Show forest plot

1

65

Mean Difference (IV, Fixed, 95% CI)

‐1.30 [‐4.54, 1.94]

4 Inotropic agent Show forest plot

1

65

Risk Difference (M‐H, Fixed, 95% CI)

‐0.37 [‐0.59, ‐0.15]
Figuras y tablas -
Comparison 2. Sildenafil versus active control
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Comparison 3. Sildenafil plus iNO versus placebo plus iNO

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 All‐cause mortality Show forest plot

1

24

Risk Difference (M‐H, Fixed, 95% CI)

0.05 [‐0.27, 0.37]

2 Length of stay in hospital (days) Show forest plot

1

24

Mean Difference (IV, Fixed, 95% CI)

5.39 [‐5.31, 16.09]

3 Inotropic agent Show forest plot

1

24

Risk Ratio (M‐H, Fixed, 95% CI)

1.06 [0.37, 3.00]

4 Duration of ventilation (days) Show forest plot

1

24

Mean Difference (IV, Fixed, 95% CI)

1.26 [‐1.32, 3.84]

5 Retinopathy of prematurity Show forest plot

1

24

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 3. Sildenafil plus iNO versus placebo plus iNO
Ir a la tabla de la revisión