Goyen Traci-Anne, Skelton Hannah, D'Cruz Daphne, Maheshwari Rajesh, Edney Bronwyn, Marceau James, Viola Patricia, Luig Melissa, Shah Dharmesh, Jani Pranav
Department of Neonatology, Westmead Hospital, Westmead, New South Wales, Australia.
Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
J Paediatr Child Health. 2025 Jul;61(7):1076-1083. doi: 10.1111/jpc.70079. Epub 2025 May 7.
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.
目的:出生后72小时内对早产儿采用头部中线位可能预防脑室内出血(IVH)。本研究探讨了开展一项随机对照试验(RCT)的可行性,具体包括:(1)招募和获得同意过程的可接受性;(2)出生后4小时内完成招募的可行性;(3)方案依从性;(4)工作人员对干预措施的满意度。 方法:采用开放标签、单中心、1:1平衡分配、平行组的试点随机对照试验。入住新生儿重症监护病房(NICU)、出生孕周小于29周、筛查超声未发现脑室内出血且出生后4小时内获得父母同意的新生儿,按孕周分层,随机分为头部中线位及仰卧体位(干预组)或可变体位(对照组),持续72小时。测量指标包括招募率、完成招募的时间、方案依从性审计和工作人员满意度调查。 结果:共纳入60名参与者,招募率为67%。6小时内开始招募和干预。头部中线位的依从性为98%。33名护士中有30名(91%)对干预措施满意度较高。未报告在稳定性、皮肤完整性、舒适度、疼痛和头部偏好方面的安全问题。 结论:开展一项随机对照试验以检验出生后72小时内对早产儿进行体位摆放的神经保护作用是可行且安全的。 试验注册:澳大利亚和新西兰临床试验注册中心:ACTRN12619000276156。
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