Midline head position for preterm infants in the first 72 hours of life: A pilot randomised control trial

AimMidline head positioning for preterm infants in the first 72 hours of life may prevent intraventricular hemorrhage (IVH). The feasibility of conducting a RCT was explored, namely (1) acceptability of the recruitment and consenting process, (2) practicality of recruitment within 4 hours of life, (3) protocol compliance, and (4) staff satisfaction with the intervention. MethodsAn open-label, single center, 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 hours of birth were randomized to either midline head and supine body position (intervention) or variable position (control) for 72 hours, stratified according to gestation. Measures were recruitment rate, time to complete recruitment, protocol compliance audit, and staff satisfaction survey. ResultsSixty participants were enrolled with recruitment rate of 67%. Recruitment and intervention were commenced by 6 hours. 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. ConclusionIt is feasible and safe to conduct a RCT to examine the neuroprotective effects of positioning the preterm infant in the first 72 hours of life. What is already knownO_LIIntraventricular haemorrhage (IVH) is common in preterm infants, mostly occurring within the first 72 hours of life. C_LIO_LIHead rotation may lead to IVH, and IVH prevention bundles often include midline head position, despite limited evidence. C_LIO_LIPrevious clinical trials have faced challenges and terminated early. C_LI What this paper addsO_LIThis pilot RCT found midline head positioning is a low-risk intervention and the protocol was feasible and safe to implement. C_LIO_LIUsing explicit consenting, inborn participants were recruited and intervention started within 6 hours after birth. C_LIO_LIThis study informs the design of future comparative effectiveness trials by including outborn infants and waiver of consent, to start the intervention immediately after birth. C_LI