仰卧位对早产儿头控影响的随机对照临床试验方案。
Effects of Prone Positioning on Head Control in Preterm Infants: Randomized and Controlled Clinical Trial Protocol.
机构信息
Post-Graduation Program of Physiotherapy, Universidade Federal do Rio Grande do Norte (UFRN), Natal 59078-970, Rio Grande do Norte, Brazil.
Departament of Physiotherapy, Universidade Federal do Rio Grande do Norte (UFRN), Natal 59078-970, Rio Grande do Norte, Brazil.
出版信息
Int J Environ Res Public Health. 2023 Jan 29;20(3):2375. doi: 10.3390/ijerph20032375.
PURPOSE
The primary aim will be to assess the effects of prone positioning (tummy time) on cervical extension (angular kinematics and time) in preterm infants. The secondary aim will be to assess the effects of tummy time on gross motor function.
METHODS
This randomized, controlled clinical trial will include 40 preterm infants weighing less than 2500 g, randomly allocated into control or experimental group (n = 20) and followed up from birth to six months of corrected age by the team of the neonatal follow-up clinic. Caregivers will be routinely guided on bonding, developmental milestones, and how to perform the tummy time for 30 min throughout the day (experimental group). An illustrative booklet will be provided as support material. The hypothesis will be tested using inferential analysis, considering an alpha of 5%.
DISCUSSION
We expect tummy time to strengthen cervical muscles needed to overcome gravity, master motor skills, and stimulate the integration between family activity and environmental experiences, considerable challenges to which preterm infants are exposed.
TRIAL REGISTRATION
Registered in the Brazilian Registry of Clinical Trials (identifier RBR-2nwkr47) on 17 February 2022.
目的
主要目的将是评估俯卧位（肚子朝下）对早产儿颈椎伸展（角度运动和时间）的影响。次要目的将是评估肚子时间对粗大运动功能的影响。
方法
这是一项随机、对照的临床试验，将包括 40 名体重不足 2500 克的早产儿，随机分为对照组和实验组（n = 20），并由新生儿随访诊所的团队从出生到纠正年龄 6 个月进行随访。护理人员将接受常规指导，包括亲子关系、发育里程碑以及如何在一天中进行 30 分钟的肚子时间（实验组）。将提供一本说明手册作为支持材料。假设将使用推理分析进行检验，考虑到 5%的α值。
讨论
我们预计肚子时间会增强克服重力、掌握运动技能和刺激家庭活动与环境体验之间整合所需的颈部肌肉，这对早产儿来说是相当大的挑战。
试验注册
于 2022 年 2 月 17 日在巴西临床试验注册处（标识符 RBR-2nwkr47）注册。
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