Study characteristics |
Methods |
Randomised controlled trial |
Participants |
8 preterm infants (29.9 to 32.1 weeks) who needed MV
Exclusion criteria: no information |
Interventions |
Midazolam group (n = 4): loading dose 0.2 mg/kg, maintenance 0.2 mg/kg/hour
Morphine group (n = 4): loading dose 0.05 mg/kg, maintenance 0.001 mg/kg/hour |
Outcomes |
Concentration changes of oxyhaemoglobin, deoxyhaemoglobin, and total haemoglobin in the brain were continuously measured with near‐infrared spectrophotometry for 1 hour Changes in cerebral blood flow velocity (pulsed Doppler US) in internal carotid artery (in %) were determined before and at 15, 30, and 60 minutes after sedation |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Random sequence generation was not specified |
Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not mentioned |
Blinding of participants and personnel (performance bias) |
Unclear risk |
Blinding was not specified |
Blinding of outcome assessment (detection bias) |
Unclear risk |
Blinding was not specified |
Incomplete outcome data (attrition bias) |
Unclear risk |
Number of infants lost to follow‐up or analysed for each outcome was not specified |
Selective reporting (reporting bias) |
Unclear risk |
Trial not registered; protocol not available |
Other bias |
Low risk |
Study appears to be free of other sources of bias |