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支持游戏探索和早期发展干预对极早产儿生命最初几个月的疗效:三臂随机临床试验方案。

Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol.

机构信息

Biokinesiology and Physical Therapy, University of Southern California, 1540 E Alcazar St, CHP 155, Los Angeles, CA 90033 (USA).

Department of Pediatrics and Neurology, University of Virginia, Charlottesville, Virginia.

出版信息

Phys Ther. 2020 Aug 12;100(8):1343-1352. doi: 10.1093/ptj/pzaa077.

DOI:10.1093/ptj/pzaa077
PMID:32329778
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7439229/
Abstract

OBJECTIVE

The aim of this project is to study the effect of a physical therapist intervention provided in the first months of life on developmental outcomes of infants born very preterm. Secondary aims are to investigate the impact of intervention timing on the efficacy and impact of the intervention on infants with and without cerebral palsy.

METHODS

This study is a multisite longitudinal controlled trial comparing developmental outcomes from infants in the Supporting Play, Exploration, and Early Development Intervention (SPEEDI)_Late or SPEEDI_Early group to a usual care group.

SETTINGS ARE URBAN

Urban and rural areas surrounding 2 academic medical centers. There will be 90 preterm infants enrolled in this study born at <29 weeks of gestation. SPEEDI is a developmental intervention provided by collaboration between a physical therapist and parent to support a child's motor and cognitive development. The primary outcome measure is the Bayley Scale of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores. Secondary measures include behavioral coding of early problem solving skills, the Gross Motor Function Measure, and Test of Infant Motor Performance.

IMPACT

More than 270,000 infants are born very preterm in the United States each year, 50% of whom will have neurological dysfunction that limits their ability to keep pace with peers who are typically developing. This study is a step toward understanding the impact that intensive developmental intervention could have in this population in the first months of life.

摘要

目的

本项目旨在研究在生命早期提供物理治疗师干预对极早产儿发育结果的影响。次要目的是研究干预时机对干预效果的影响,以及干预对脑瘫和非脑瘫婴儿的影响。

方法

这是一项多中心纵向对照试验,比较支持游戏、探索和早期发展干预(SPEEDI)_晚期或 SPEEDI_早期组与常规护理组婴儿的发育结果。

设置为城市

在 2 家学术医疗中心周围的城市和农村地区。本研究将纳入 90 名胎龄<29 周的早产儿。SPEEDI 是一种由物理治疗师和家长合作提供的发育干预措施,以支持儿童的运动和认知发展。主要结局指标是贝利婴幼儿发展量表认知和粗大运动量表评分。次要指标包括早期解决问题技能的行为编码、粗大运动功能测量和婴儿运动表现测试。

影响

美国每年有超过 27 万名婴儿极早产,其中 50%的婴儿会出现神经功能障碍,限制其跟上正常发育的同龄人的步伐。这项研究是朝着理解在生命早期进行强化发育干预对这一人群可能产生的影响迈出的一步。

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本文引用的文献

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Supporting play exploration and early developmental intervention versus usual care to enhance development outcomes during the transition from the neonatal intensive care unit to home: a pilot randomized controlled trial.支持游戏探索和早期发育干预与常规护理相比,以改善从新生儿重症监护病房过渡到家庭期间的发育结果:一项试点随机对照试验。
BMC Pediatr. 2018 Feb 9;18(1):46. doi: 10.1186/s12887-018-1011-4.
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Social Disparities in Early Intervention Service Use and Provider-Reported Outcomes.早期干预服务使用情况及提供者报告结果中的社会差异
J Dev Behav Pediatr. 2017 Sep;38(7):501-509. doi: 10.1097/DBP.0000000000000474.
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Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment.脑性瘫痪的早期准确诊断与早期干预:诊断与治疗进展
JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
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Routine Magnetic Resonance Imaging at Term-Equivalent Age Detects Brain Injury in 25% of a Contemporary Cohort of Very Preterm Infants.足月相当年龄时的常规磁共振成像在当代一组极早产儿中检测出25%存在脑损伤。
PLoS One. 2017 Jan 3;12(1):e0169442. doi: 10.1371/journal.pone.0169442. eCollection 2017.
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Part C Early Intervention Enrollment in Low Birth Weight Infants At-Risk for Developmental Delays.C部分 对有发育迟缓风险的低体重婴儿进行早期干预登记
Matern Child Health J. 2017 Feb;21(2):290-296. doi: 10.1007/s10995-016-2113-y.
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Early prediction of typical outcome and mild developmental delay for prioritisation of service delivery for very preterm and very low birthweight infants: a study protocol.极早产儿和极低出生体重儿服务提供优先级的典型结局和轻度发育迟缓的早期预测:一项研究方案
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