Al‐Abdi 2011.
| Study characteristics | ||
| Methods | Randomised parallel clinical trial, conducted at King Abdulaziz Hospital, Al‐Ahsa, Saudi Arabia, and including 48 preterm infants in 2008 to 2009. Randomisation was stratified on the basis of gender and gestational age (< 27 or 27 to 29+6 weeks). Randomisation was carried out according to a predetermined computer‐generated randomisation sequence with consecutively numbered sealed envelopes. In the case of eligible multiple births, each infant was randomly assigned. An intention‐to‐treat analysis was used throughout this study. Among infants in the head midline group, 12 were cared for in a left‐tilted and 13 in a right‐tilted midline head position | |
| Participants | Preterm infants were enrolled in the trial if they met the following criteria: (1) inborn; (2) gestational age < 30 weeks; and (3) postnatal age < 2 hours. Exclusion criteria included the presence of lethal congenital anomalies, hypoxic‐ischaemic encephalopathy, and the need for full cardiopulmonary resuscitation at birth | |
| Interventions | Infants lying on beds at 0° were randomly assigned to be cared for in a supine midline (23 infants) or supine lateral (25 infants) head position. In the supine midline position, the infant’s chin was kept at a 90° angle to the bed. In the lateral head position, the head was tilted 90° to either side. At enrolment, it was left to the bedside nurse to place the head in the right‐tilted or left‐titled position | |
| Outcomes | Primary outcome: rate of intraventricular haemorrhage of all grades Secondary outcomes: rate of intraventricular haemorrhage, grade 3 to 4; neonatal mortality; retinopathy of prematurity (any stage; ≥ stage 3); cystic periventricular leukomalacia |
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| Notes | This was a pilot study (underpowered) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was carried out according to a predetermined computer‐generated randomisations sequence |
| Allocation concealment (selection bias) | Low risk | Envelopes for randomisations were opaque (we obtained data for this outcome directly from trial authors) |
| 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 assessed by 2 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) | Unclear risk | Study protocol not available |
| Other bias | Unclear risk | Trial was underpowered (pilot) |