Methods |
Single centre
Blinding of randomization ‐ can't tell
Blinding of intervention ‐ no
Complete follow‐up ‐ yes
Blinding of outcome measure ‐ can't tell |
Participants |
16 preterm infants (mean gestational age 30 weeks) enrolled infants where ≥ 3 severe apneas noted per 24 hours |
Interventions |
Exp: standard caffeine = loading dose 10 mg/kg intramuscularly, daily maintenance dose 2.5 mg/kg orally to target serum level of 8 ‐ 16 mg/l)
Control: Aminophylline used as theophylline = loading dose 5.5 mg/kg intravenously, maintenance dose adjusted to maintain plasma levels at 5 ‐ 10 mg/kg |
Outcomes |
Apnea frequency on day 0, 1, and 5
Tachycardia
Weight |
Notes |
Severe apnea defined as cessation of breathing for 10 secs with heart rate < 80 for > 30 seconds or <60 for > 15 seconds |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
Unclear |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
No blinding of interventions, blinding of outcome assessments unclear |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All studied |
Selective reporting (reporting bias) |
Low risk |
No selective cases reported |
Other bias |
Unclear risk |
None stated |