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

Adel 2010.

Study characteristics
Methods Single‐centre, quasi‐randomised trial where neonates with suspected sepsis were randomised to pentoxifylline if they were admitted on Tuesday or Thursday and to placebo if admitted on Monday or Wednesday
Period of study: December 2007 and August 2008
No concealment of allocation
Blinding of intervention: yes
Blinding of outcome assessment: unclear
Completeness of follow‐up: yes
Participants Single centre, at Ain Shams University, Cairo, Egypt
Total participants: 37
PTX group: n = 17 (gestational age 35.94 ± 4.04 weeks, bwt 2.47 ± 0.89 kg)
Control group: n = 20 (gestational age 36.05 ± 3.12 weeks, bwt 2.21 ± 0.59 kg)
Neonates with suspected sepsis with maternal and clinical risk factors
Maternal risk factors: fever ≥ 38 °C or premature rupture of membranes > 36 hours, or both
Neonatal risk factors: elevated C‐reactive protein and abnormalities of complete blood count, deterioration of respiratory and cardiac functions, feeding intolerance, abdominal distension, temperature instability, lethargy or irritability, and hepatosplenomegaly
The intervention and placebo groups did not differ significantly in gestational age, birthweight, or Apgar scores.
Interventions Pentoxifylline (5 mg/kg/h for 6 hours for 6 consecutive days) or placebo (equal volume of normal saline for 6 consecutive days) as an adjunct to antibiotics
Outcomes Mortality, length of hospital stay, multi‐organ dysfunction, coagulation profiles including platelet count and C‐reactive protein, shock, and NEC
Notes 6 of 37 neonates with sepsis were culture‐negative, and outcomes were not reported separately for this group.
Funding sources or declarations of interest were not stated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not clear
Allocation concealment (selection bias) High risk No allocation concealment due to quasi‐randomisation by day of the week
Blinding (performance bias and detection bias)
All outcomes High risk Test drug and placebo dispensed in similar syringes, but participants were quasi‐randomised based on the day of admission. Hence, the efficacy of the blinding unclear.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Unclear.
Incomplete outcome data (attrition bias)
All outcomes Low risk Outcomes for all infants reported.
Selective reporting (reporting bias) Low risk None noted
Other bias Low risk None noted