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支持早产儿游戏、探索和早期发展干预(SPEEDI):澳大利亚背景下的一项可行性随机对照试验。

Supporting Play, Exploration, and Early Development Intervention (SPEEDI) for preterm infants: A feasibility randomised controlled trial in an Australian context.

机构信息

The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.

Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, Victoria 3052, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.

出版信息

Early Hum Dev. 2020 Dec;151:105172. doi: 10.1016/j.earlhumdev.2020.105172. Epub 2020 Sep 1.

Abstract

BACKGROUND

An early intervention that enhances early development in infants born preterm, called 'Supporting Play, Exploration and Early Development Intervention' (SPEEDI) has been shown to be feasible in Virginia, United States, in a pilot study. Infants receive 10 therapy sessions until 3 months' corrected age (CA) (Phase 1[5 hospital sessions] and Phase 2[5 home-based sessions]) in addition to usual care.

AIMS

To determine the feasibility of SPEEDI for very preterm infants in an Australian context.

STUDY DESIGN

Prospective pilot feasibility randomised controlled trial.

SUBJECTS

Infants born <30 weeks' gestation (GA), recruited between 34 and 38 weeks' postmenstrual age.

OUTCOME MEASURES

Primary outcome was feasibility of SPEEDI, including recruitment rate, participant retention, sessions delivered, and therapy fidelity. Secondary outcome measures were developmental outcomes, including the Bayley Scales of Infant and Toddler Development - 3rd Edition (BSID-III) at 4 months' CA.

RESULTS

Of 19 eligible infants, 17 consented, SPEEDI n = 8 and usual care n = 9 (mean GA = 26.7 weeks [SD 1.4], male n = 10). All participants completed the study, with 80% of SPEEDI therapy sessions completed (90% Phase 1; 72% Phase 2). On average, therapists and parents used 78% and 77% of SPEEDI strategies in each session respectively. Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.

CONCLUSIONS

SPEEDI is a feasible intervention to deliver, and preliminary results suggest that SPEEDI may lead to improved motor and language outcomes at 4 months' CA, with results supporting future larger clinical trials.

摘要

背景

在美国弗吉尼亚州的一项试点研究中,一种名为“支持游戏、探索和早期发展干预”(Supporting Play, Exploration and Early Development Intervention,SPEEDI)的早期干预措施已被证明可促进早产儿的早期发育。除了常规护理外,婴儿在 3 个月校正年龄(CA)前接受 10 次治疗(第 1 阶段[5 次医院治疗]和第 2 阶段[5 次家庭治疗])。

目的

确定 SPEEDI 在澳大利亚早产儿中的可行性。

研究设计

前瞻性试点可行性随机对照试验。

受试者

招募时胎龄(GA)<30 周的婴儿,招募时间为出生后 34 至 38 周的月经龄。

结局测量

主要结局是 SPEEDI 的可行性,包括招募率、参与者保留率、治疗方案的实施和治疗的保真度。次要结局是发育结局,包括 4 个月 CA 的贝利婴幼儿发育量表第三版(Bayley Scales of Infant and Toddler Development-3rd Edition,BSID-III)。

结果

在 19 名符合条件的婴儿中,有 17 名同意参加研究,其中 SPEEDI 组 n=8 名,常规护理组 n=9 名(平均 GA=26.7 周[SD 1.4],男性 n=10)。所有参与者均完成了研究,80%的 SPEEDI 治疗方案完成(第 1 阶段 90%,第 2 阶段 72%)。平均而言,治疗师和家长在每个治疗方案中分别使用了 78%和 77%的 SPEEDI 策略。SPEEDI 组的婴儿在 4 个月 CA 时在大运动、表达和接受语言子量表上的 BSID-III 评分更高。

结论

SPEEDI 是一种可行的干预措施,初步结果表明 SPEEDI 可能会导致婴儿在 4 个月 CA 时运动和语言方面的结果得到改善,结果支持未来更大规模的临床试验。

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