Abstract
AIM: Midline head positioning for preterm infants in the first 72 h of life may prevent intraventricular haemorrhage (IVH). The feasibility of conducting a RCT was explored, namely (1) acceptability of the recruitment and consenting process, (2) practicality of recruitment within 4 h after birth, (3) protocol compliance, and (4) staff satisfaction with the intervention. METHODS: An open-label, single centre, balanced 1:1 allocation, parallel-group pilot RCT was adopted. Inborn infants < 29 weeks admitted to the NICU with no IVH on screening ultrasound and parental consent obtained within 4 h after birth were randomised to either midline head and supine body position (intervention) or variable position (control) for 72 h, stratified according to gestation. Measures were recruitment rate, time to complete recruitment, protocol compliance audit, and staff satisfaction survey. RESULTS: Sixty participants were enrolled with a recruitment rate of 67%. Recruitment and intervention were commenced by 6 h. Compliance was 98% for midline head position. Nursing satisfaction was positive in 30/33 (91%). No safety issues were reported for stability, skin integrity, comfort, pain, and head preference. CONCLUSION: It is feasible and safe to conduct a RCT to examine the neuroprotective effects of positioning the preterm infant in the first 72 h after birth. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN12619000276156.