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随机对照试验方案:袋鼠式皮肤接触联合感觉运动干预对早产儿的影响。

Randomized Controlled Trial Protocol on the Effects of a Sensory Motor Intervention Associated with Kangaroo Skin-to-Skin Contact in Preterm Newborns.

机构信息

Graduate Program in Health and Development, Faculty of Medicine, Federal University of Mato Grosso do Sul, Campo Grande 79070-900, Brazil.

Graduate Program in Movement Sciences, Institute of Health, Federal University of Mato Grosso do Sul, Campo Grande 79070-900, Brazil.

出版信息

Int J Environ Res Public Health. 2024 Apr 25;21(5):538. doi: 10.3390/ijerph21050538.

Abstract

There is still very limited evidence on the effects of neonatal interventions on infant neurodevelopmental outcomes, including general movements (GMs). This research will primarily assess the effects of a sensory motor physical therapy intervention combined with kangaroo skin-to-skin contact on the GMs of hospitalized preterm newborns. Secondary outcomes include body weight, posture and muscle tone, behavioral state, length of hospital stay, and breastfeeding. This study protocol details a two-arm parallel clinical trial methodology, involving participants with a postmenstrual age of 34-35 weeks admitted to a Neonatal Intermediate Care Unit (NInCU) with poor repertoire GMs. Thirty-four participants will be randomly assigned to either the experimental group, receiving a 10-day sensory motor physical therapy associated with kangaroo skin-to-skin contact, or the control group, which will only receive kangaroo skin-to-skin contact. The study will measure GMs (primary outcome), and body weight, posture and muscle tone, behavioral state, length of hospital stay, and breastfeeding (secondary outcomes). Data collection occurs in the NInCU before and after the intervention, with follow-up measurements post discharge at 2-4 weeks and 12-15 weeks post-term. SPSS will be used for data analyses. The results will provide novel information on how sensory motor experiences may affect early neurodevelopment and clinical variables in preterm newborns.

摘要

关于新生儿干预对婴儿神经发育结果的影响,包括一般运动(GMs),目前仍只有非常有限的证据。本研究将主要评估结合袋鼠式皮肤接触的感觉运动物理治疗干预对住院早产儿 GMs 的影响。次要结果包括体重、姿势和肌张力、行为状态、住院时间和母乳喂养。本研究方案详细介绍了一项两臂平行临床试验方法,涉及胎龄为 34-35 周的参与者,他们被收入新生儿中间护理病房(NInCU),GMs 表现不佳。34 名参与者将被随机分配到实验组或对照组,实验组接受为期 10 天的感觉运动物理治疗结合袋鼠式皮肤接触,对照组仅接受袋鼠式皮肤接触。研究将测量 GMs(主要结果)以及体重、姿势和肌张力、行为状态、住院时间和母乳喂养(次要结果)。干预前后在 NInCU 进行数据收集,出院后 2-4 周和 12-15 周时进行随访测量。将使用 SPSS 进行数据分析。研究结果将提供有关感觉运动体验如何影响早产儿早期神经发育和临床变量的新信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3522/11121349/d0ffff4f8df7/ijerph-21-00538-g001.jpg

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