Antibiotics for neonates born through meconium‐stained amniotic fluid

Lauren E Kelly; Sandesh Shivananda; Prashanth Murthy; Ravisha Srinivasjois; Prakeshkumar S Shah

doi:10.1002/14651858.CD006183.pub2

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Figure 1

Figure 1. Study flow diagram.

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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.

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Figure 3

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

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Figure 4

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

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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.

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Analysis 1.2

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

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Analysis 1.3

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

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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.

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Analysis 1.6

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

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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.

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Analysis 1.8

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

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Analysis 1.9

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

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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.

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Analysis 2.2

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

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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.

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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.

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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.

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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.

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Analysis 2.7

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

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Analysis 2.8

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

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Analysis 2.9

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

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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.

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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).

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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.

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Analysis 2.13

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

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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

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

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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

Summary of findings 2. Antibiotics compared with control (no antibiotics) in asymptomatic neonates born through meconium‐stained amniotic fluid

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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]

Comparison 1. Antibiotics versus control (no antibiotics) in symptomatic neonates

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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]

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

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