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

Ali 2006.

Study characteristics
Methods Single‐centre trial at Sher‐i‐Kashmir Institute of Medical Sciences (SKIMS), Srinagar, India
Period of study: October 2004 to November 2005
Randomisation details not reported.
Concealment of allocation: unclear
Blinding of intervention: no
Blinding of outcome assessment: unclear
Completeness of follow‐up: yes
Participants 50 premature infants with culture‐proven sepsis (< 37 weeks' gestational age); 25 in PTX group and 25 in control group 
Inclusion criteria: culture‐proven sepsis, gestation < 37 weeks, clinical signs of sepsis including cardiovascular and respiratory dysfunction, and written consent
Exclusion criteria: intraventricular haemorrhage, congenital infection, and culture negativity
Gestational age in both the treatment and placebo groups ranged from 32 to 37 weeks.
Birthweight ranged from 950 g to 2580 g in the treatment group, and 1000 g to 2650 g in the control group.
42/50 of enroled infants had gram‐negative sepsis.
Interventions Pentoxifylline intravenously (5 mg/kg/h for 6 hours for 3 consecutive days) in conjunction with antibiotics or control group who received antibiotics
First‐line antibiotics were amoxicillin + clavulanic acid and amikacin
Outcomes Mortality, development of NEC, length of hospital stay, duration of ventilation, and adverse effects (hypertension, irritability, deterioration of vital signs) were reported.
Notes Although mean length of hospital stay and duration of ventilation were reported, standard deviations were not, and so not included in meta‐analyses.
Funding sources and 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) Unclear risk No details of randomisation reported.
Blinding (performance bias and detection bias)
All outcomes High risk None reported.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Unclear.
Incomplete outcome data (attrition bias)
All outcomes Low risk Outcomes for all participants reported.
Selective reporting (reporting bias) Low risk None noted
Other bias Low risk None noted