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Figure 1. Study flow diagram.
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Figure 1

Figure 1. Study flow diagram.

Figure 2. Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Figure 2. Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Forest plot of comparison: Incidence of confirmed sepsis in symptomatic neonates within the first 28 days.
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Figure 3

Forest plot of comparison: Incidence of confirmed sepsis in symptomatic neonates within the first 28 days.

Forest plot of comparison: Mortality in symptomatic neonates (before discharge).
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Figure 4

Forest plot of comparison: Mortality in symptomatic neonates (before discharge).

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 1 Incidence of confirmed sepsis in first 28 days.
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Analysis 1.1

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 1 Incidence of confirmed sepsis in first 28 days.

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 2 Mortality (before discharge).
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Analysis 1.2

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 2 Mortality (before discharge).

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 3 Duration of oxygen therapy, days.
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Analysis 1.3

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 3 Duration of oxygen therapy, days.

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 4 Duration of hospital stay, days.
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Analysis 1.4

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 4 Duration of hospital stay, days.

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 5 Incidence of pulmonary air leak syndrome.
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Analysis 1.5

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 5 Incidence of pulmonary air leak syndrome.

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 6 Incidence of mechanical ventilation.
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Analysis 1.6

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 6 Incidence of mechanical ventilation.

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 7 Time to clear chest radiograph, days.
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Analysis 1.7

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 7 Time to clear chest radiograph, days.

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 8 Incidence of respiratory failure.
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Analysis 1.8

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 8 Incidence of respiratory failure.

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 9 Duration of respiratory distress, hours.
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Analysis 1.9

Comparison 1 Antibiotics versus control (no antibiotics) in symptomatic neonates, Outcome 9 Duration of respiratory distress, hours.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 1 Incidence of confirmed sepsis in first 28 days.
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Analysis 2.1

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 1 Incidence of confirmed sepsis in first 28 days.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 2 Mortality (before discharge).
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Analysis 2.2

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 2 Mortality (before discharge).

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 3 Duration of mechanical ventilation, days.
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Analysis 2.3

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 3 Duration of mechanical ventilation, days.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 4 Duration of oxygen therapy, days.
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Analysis 2.4

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 4 Duration of oxygen therapy, days.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 5 Incidence of suspected sepsis.
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Analysis 2.5

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 5 Incidence of suspected sepsis.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 6 Incidence of intracranial haemorrhage.
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Analysis 2.6

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 6 Incidence of intracranial haemorrhage.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 7 Incidence of azotaemia.
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Analysis 2.7

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 7 Incidence of azotaemia.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 8 Incidence of oliguria.
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Analysis 2.8

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 8 Incidence of oliguria.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 9 Incidence of diarrhoea.
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Analysis 2.9

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 9 Incidence of diarrhoea.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 10 Incidence of mechanical ventilation.
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Analysis 2.10

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 10 Incidence of mechanical ventilation.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 11 Incidence of respiratory distress (Downe's score).
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Analysis 2.11

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 11 Incidence of respiratory distress (Downe's score).

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 12 Duration of respiratory distress, hours.
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Analysis 2.12

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 12 Duration of respiratory distress, hours.

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 13 Incidence of MAS.
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Analysis 2.13

Comparison 2 Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates, Outcome 13 Incidence of MAS.

Summary of findings for the main comparison. Antibiotics compared with control (no antibiotics) in symptomatic neonates born through meconium‐stained amniotic fluid

Antibiotics compared with control (no antibiotics) in symptomatic neonates born through meconium‐stained amniotic fluid

Patient or population: symptomatic neonates born through meconium‐stained amniotic fluid
Setting: neonatal intensive care unit
Intervention: antibiotics
Comparison: control (no antibiotics)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with control (no antibiotics)

Risk with antibiotics

Incidence of confirmed sepsis in first 28 days

Study population

Not estimable

445
(3 RCTs)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to unclear risk of bias due to methodological limitations, including a large number of dropouts; and imprecision resulting from a small sample size

9 per 1000

0 per 1000
(0 to 0)

Mortality (before discharge)

Study population

RR 1.69
(0.23 to 12.53)

445
(3 RCTs)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to unclear risk of bias due to methodological limitations, including a large number of dropouts; and imprecision resulting from a small sample size

5 per 1000

8 per 1000
(1 to 57)

Duration of oxygen therapy, days

Mean duration of oxygen therapy (days) was 0

MD 0.85 days lower
(1.19 lower to 0.52 lower)

405
(2 RCTs)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to unclear risk of bias due to methodological limitations, including a large number of dropouts; and imprecision resulting from a small sample size

Duration of hospital stay, days

Mean duration of hospital stay (days) was 0

MD 0.16 days higher
(1.15 lower to 1.47 higher)

146
(1 RCT)

⊕⊕⊕⊝
MODERATE

Evidence was downgraded owing to imprecision resulting from a small sample size

Incidence of mechanical ventilation

Study population

RR 1.18
(0.52 to 2.67)

445
(3 RCTs)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to unclear risk of bias due to methodological limitations, including a large number of dropouts; and imprecision resulting from a small sample size

45 per 1000

53 per 1000
(24 to 121)

Incidence of respiratory failure

Study population

RR 1.20
(0.51 to 2.83)

405
(2 RCTs)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to unclear risk of bias due to methodological limitations, including a large number of dropouts; and imprecision resulting from a small sample size

41 per 1000

47 per 1000
(20 to 113)

*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 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

Figures and Tables -
Summary of findings for the main comparison. Antibiotics compared with control (no antibiotics) in symptomatic neonates born through meconium‐stained amniotic fluid
Summary of findings 2. Antibiotics compared with control (no antibiotics) in asymptomatic neonates born through meconium‐stained amniotic fluid

Antibiotics compared with control (no antibiotics) in asymptomatic neonates born through meconium‐stained amniotic fluid

Patient or population: asymptomatic neonates born through meconium‐stained amniotic fluid
Setting: neonatal intensive care unit
Intervention: antibiotics
Comparison: control (no antibiotics)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with control (no antibiotics)

Risk with antibiotics

Incidence of confirmed sepsis in first 28 days

Study population

Not estimable

250
(1 RCT)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to very serious imprecision, as the results from this study have not been replicated

54 per 1000

0 per 1000
(0 to 0)

Mortality (before discharge)

Study population

RR 1.07
(0.22 to 5.18)

250
(1 RCT)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to very serious imprecision, as the results from this study have not been replicated

23 per 1000

25 per 1000
(5 to 120)

Duration of oxygen therapy, days

Mean duration of oxygen therapy (days) was 0

MD 0.43 days higher
(0.13 higher to 0.73 higher)

250
(1 RCT)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to very serious imprecision, as the results from this study have not been replicated

Incidence of suspected sepsis

Study population

Not estimable

250
(1 RCT)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to very serious imprecision, as the results from this study have not been replicated

109 per 1000

0 per 1000
(0 to 0)

Incidence of mechanical ventilation

Study population

RR 2.13
(0.55 to 8.34)

250
(1 RCT)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to very serious imprecision, as the results from this study have not been replicated

23 per 1000

50 per 1000
(13 to 194)

Duration of respiratory distress, hours

Mean duration of respiratory distress (hours) was 0

MD 6.87 higher
(4.22 higher to 9.52 higher)

250
(1 RCT)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to very serious imprecision, as the results from this study have not been replicated

Incidence of MAS

Study population

RR 1.17
(0.67 to 2.04)

250
(1 RCT)

⊕⊕⊝⊝
LOW

Evidence was downgraded owing to very serious imprecision, as the results from this study have not been replicated

155 per 1000

181 per 1000
(104 to 316)

*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 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

Figures and Tables -
Summary of findings 2. Antibiotics compared with control (no antibiotics) in asymptomatic neonates born through meconium‐stained amniotic fluid
Comparison 1. Antibiotics versus control (no antibiotics) in symptomatic neonates

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Incidence of confirmed sepsis in first 28 days Show forest plot

3

445

Risk Difference (M‐H, Fixed, 95% CI)

0.00 [‐0.02, 0.03]

2 Mortality (before discharge) Show forest plot

3

445

Risk Difference (M‐H, Fixed, 95% CI)

0.00 [‐0.01, 0.02]

3 Duration of oxygen therapy, days Show forest plot

2

405

Mean Difference (IV, Fixed, 95% CI)

‐0.85 [‐1.19, ‐0.52]

4 Duration of hospital stay, days Show forest plot

1

146

Mean Difference (IV, Fixed, 95% CI)

0.16 [‐1.15, 1.47]

5 Incidence of pulmonary air leak syndrome Show forest plot

3

445

Risk Ratio (M‐H, Fixed, 95% CI)

1.50 [0.62, 3.67]

6 Incidence of mechanical ventilation Show forest plot

3

445

Risk Ratio (M‐H, Fixed, 95% CI)

1.18 [0.52, 2.67]

7 Time to clear chest radiograph, days Show forest plot

1

146

Mean Difference (IV, Fixed, 95% CI)

‐1.31 [‐3.04, 0.42]

8 Incidence of respiratory failure Show forest plot

2

405

Risk Difference (M‐H, Fixed, 95% CI)

0.01 [‐0.03, 0.05]

9 Duration of respiratory distress, hours Show forest plot

1

40

Mean Difference (IV, Random, 95% CI)

‐1.20 [‐25.59, 23.19]

Figures and Tables -
Comparison 1. Antibiotics versus control (no antibiotics) in symptomatic neonates
Comparison 2. Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Incidence of confirmed sepsis in first 28 days Show forest plot

1

250

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.07, 0.04]

2 Mortality (before discharge) Show forest plot

1

250

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.22, 5.18]

3 Duration of mechanical ventilation, days Show forest plot

1

250

Mean Difference (IV, Fixed, 95% CI)

0.26 [0.15, 0.37]

4 Duration of oxygen therapy, days Show forest plot

1

250

Mean Difference (IV, Fixed, 95% CI)

0.43 [0.13, 0.73]

5 Incidence of suspected sepsis Show forest plot

1

250

Risk Difference (M‐H, Fixed, 95% CI)

‐0.03 [‐0.10, 0.05]

6 Incidence of intracranial haemorrhage Show forest plot

1

250

Risk Ratio (M‐H, Fixed, 95% CI)

0.36 [0.01, 8.64]

7 Incidence of azotaemia Show forest plot

1

250

Risk Ratio (M‐H, Fixed, 95% CI)

3.20 [0.13, 77.73]

8 Incidence of oliguria Show forest plot

1

250

Risk Ratio (M‐H, Fixed, 95% CI)

3.20 [0.13, 77.73]

9 Incidence of diarrhoea Show forest plot

1

250

Risk Ratio (M‐H, Fixed, 95% CI)

0.12 [0.01, 2.18]

10 Incidence of mechanical ventilation Show forest plot

1

250

Risk Ratio (M‐H, Fixed, 95% CI)

2.13 [0.55, 8.34]

11 Incidence of respiratory distress (Downe's score) Show forest plot

1

250

Risk Ratio (M‐H, Fixed, 95% CI)

1.18 [0.81, 1.72]

12 Duration of respiratory distress, hours Show forest plot

1

250

Mean Difference (IV, Fixed, 95% CI)

6.87 [4.22, 9.52]

13 Incidence of MAS Show forest plot

1

250

Risk Ratio (M‐H, Fixed, 95% CI)

1.17 [0.67, 2.04]

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Comparison 2. Antibiotics versus control (no antibiotics) for prevention in asymptomatic neonates