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. 2023 Jun 20;2023(6):CD004205. doi: 10.1002/14651858.CD004205.pub4

Summary of findings 1. Pentoxifylline with antibiotics (any dose or duration) compared to placebo or no intervention for neonatal sepsis.

Pentoxifylline with antibiotics (any dose or duration) compared to placebo with antibiotics or antibiotics alone for neonatal sepsis
Patient or population: neonates with sepsis
Settings: neonatal intensive care unit
Intervention: PTX
Comparison: placebo
Outcomes Illustrative comparative risks* (95% CI) Relative effect
(95% CI) No. of participants
(studies) Certainty of the evidence
(GRADE)
Assumed risk Corresponding risk
Placebo PTX
All‐cause mortality during hospital stay
 
36/207 20/209 RR 0.57 (0.35, 0.93) 416 participants
(6 studies) ⊕⊕⊝⊝
Lowa
 
Chronic lung disease
 
4/60 6/60 RR 1.50 (0.45, 5.05) 120 participants
(1 study) ⊕⊝⊝⊝
Very lowb
 
Severe intraventricular haemorrhage 8/60 6/60 RR 0.75 (0.28, 2.03) 120 participants
(1 study) ⊕⊝⊝⊝
Very lowb
 
Periventricular leukomalacia
 
4/60 2/60 RR 0.50 (0.10, 2.63) 120 participants
(1 study) ⊕⊝⊝⊝
Very lowb
 
Length of hospital stay (LOS) in days The mean LOS ranged across control groups from 33.8 to 38.3 days. The mean LOS in the intervention groups was 22.6 to 31.3 days.
  Mean difference
−7.74, 95% CI −11.72, −3.76
157 participants
(2 studies) ⊕⊕⊝⊝
Lowc
 
Necrotising enterocolitis, any Bell stage 13/203 23/202 RR 0.56 (0.29, 1.06) 405 participants
(6 studies) ⊕⊝⊝⊝
Very lowd
Retinopathy of prematurity, any stage
 
5/60 2/60 RR 0.40 (0.08, 1.98) 120 participants
(1 study) ⊕⊝⊝⊝
Very lowb
 
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; PTX: pentoxifylline; RR: risk ratio
GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: 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 certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aDowngraded to low because four studies had a high risk of bias, and the summary estimate was imprecise with wide CIs.

bDowngraded to very low because there was only one included study and due to imprecision of the summary estimate.

cDowngraded to low because there were only two included studies, one of which had a high risk of bias.

dDowngraded to very low because three studies had a high risk of bias, and the summary estimate was imprecise with wide CIs.