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 |
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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. |
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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. |
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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 |