Methods | Multicenter randomized (block size of 4) parallel clinical trial. Head ultrasound scan was performed within 12 hours of life, at 168 hours of life, and at the physician's discretion. Head ultrasound scan was reported by 3 radiologists who were blinded to assignment of head position. The primary analysis was by intention to treat | |
Participants | Preterm neonates (< 30 weeks' gestation) without intraventricular hemorrhage at 12 hours of life scan Exclusion criteria: outborn; lethal congenital anomalies; hypoxic ischemic encephalopathy; external cardiac compression or epinephrine administration at birth |
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Interventions | Heads of 62 preterm neonates were randomly placed in flat midline (n = 31) or flat right lateral position (n = 31) throughout the first 168 hours of life | |
Outcomes | The only outcome reported in the abstract was intraventricular hemorrhage | |
Notes | Although the planned sample size was 600 (alpha 5%; power 80%), the study was prematurely terminated owing to low accrual rate when only 71 neonates (12%) had been recruited Trial was registered on https://clinicaltrials.gov/ct2/show/NCT01584375 and findings presented at the Pediatric Academic Societies (PAS) in 2015 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomization not stated |
Allocation concealment (selection bias) | Unclear risk | Method of allocation not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Head ultrasound scans were reported by 3 radiologists who were blinded to assignment of head position |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | Study protocol available |
Other bias | High risk | Trial lacks power because only 71 infants were enrolled (instead of 600) |