Methods |
Single centre
Blinding of randomization ‐ yes in sealed envelopes
Blinding of intervention ‐ yes
Complete followup ‐ yes *
Blinding of outcome measure ‐ yes
*extra information provided by the author (personal correspondence) |
Participants |
20 preterm infants (mean gestational age 30 weeks) included after 24 hour recording documented ≥ 3 apneas |
Interventions |
Exp: standard caffeine = loading dose 10 mg/kg, maintenance dose 1.25 mg/kg/12hrs
Control: theophylline = loading dose 6 mg/kg, maintenance dose 2 mg/kg/12hrs |
Outcomes |
Frequency of apnea, bradycardia, apnea with bradycardia, systolic arterial pressure, tachycardia, weight gain, gastrointestinal intolerance, behavioural assessment (scaled‐score of motor activity, reactivity and sucking). |
Notes |
Apnea defined as cessation of breathing of 15 seconds or more, or apnea plus bradycardia (<100). Author communication indicated that these were collected separately and in the review they were combined for primary outcome measure. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
Adequate |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Both interventions and outcome assessments |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All studied |
Selective reporting (reporting bias) |
Low risk |
None selected |
Other bias |
High risk |
Assisted by author correspondence |