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早产儿入住单人家庭病房与开放式新生儿重症监护病房的长期结局比较：一项随机对照试验

Long-term outcomes of preterm infants admitted to single-family rooms versus an open-bay neonatal intensive care unit: A randomized controlled trial.

临床研究耳科IF 2.6Q2

文献信息

PMID42864367
原文在 PubMed 查看原文 ↗
发表日期2026
作者Michael J Vincer
查看其他 14 位作者

Christy G Woolcott；Darlene J Inglis；Tanya M Myles；Susan M MacDonald；Jehier Afifi；C David Simpson；Satvinder Ghotra；Walid El-Naggar；Balpreet Singh；Danielle Styranko；Sharon Unger；Souvik Mitra；Douglas D McMillan；Jon S Dorling

作者单位Department of Pediatrics, Dalhousie University, Halifax, NS, Canada. vincer@dal.ca.
查看其他 5 条单位信息

Departments of Pediatrics and Obstetrics & Gynecology, Perinatal Epidemiology Unit, Dalhousie University, Halifax, NS, Canada.；Department of Nursing, Izaak Walton Killam Health, Halifax, NS, Canada.；Department of Pediatrics, Dalhousie University, Halifax, NS, Canada.；Department of Pediatrics, University of British Columbia, British Columbia, Vancouver, BC, Canada.；Child Health Outcomes Research At Leeds, University of Leeds, Leeds, UK.

期刊Journal of perinatology : official journal of the California Perinatal Association
SCI 分区Q2
IF2.6
研究类型临床研究 · 临床
所属专科耳科

中文摘要

目的： 比较早产儿在单人家庭病房（SFR）与开放式（OB）新生儿重症监护病房（NICU）中的长期结局。
研究设计： 这项随机对照试验于2018年4月至2019年6月在一家三级NICU进行。胎龄<31周或出生体重≤1500克的婴儿在入院时被随机分配至SFR或OB。主要结局为校正年龄36个月时的死亡或神经发育损害（NDI；脑性瘫痪、语言发育迟缓、认知发育迟缓、失明或耳聋）。次要结局为死亡率、NDI各组成部分及安全性指标。
结果： 在85名婴儿（43名SFR，42名OB）中，主要结局无差异（SFR 40.5% vs OB 47.4%，p=0.644）。除死亡率外，次要结局无差异，SFR死亡率（1/41，2.4%）低于OB（8/42，19.0%），p=0.029。
结论： 校正年龄36个月时死亡/NDI的复合结局相似；然而，在SFR中观察到死亡率降低。该试验于2019年3月6日在ClinicalTrials.gov注册，NCT03867669（https://clinicaltrials.gov/search?cond=NCT03867669）。

英文摘要

OBJECTIVE: To compare long-term outcomes of preterm infants in single-family room (SFR) vs. open-bay (OB) neonatal intensive care unit (NICU).
STUDY DESIGN: This randomized controlled trial took place in a tertiary NICU from April 2018 to June 2019. Infants <31 weeks gestation or ≤1500 grams birthweight were randomly assigned upon admission to SFR or OB. The primary outcome was death or neurodevelopmental impairment (NDI; cerebral palsy, language delay, cognitive delay, blindness, or deafness) at 36 months corrected age. Secondary outcomes were mortality, NDI components, and safety measures.
RESULTS: Of 85 infants (43 SFR, 42 OB), there was no difference in primary outcome (40.5% SFR vs. 47.4% OB, p = 0.644). Secondary outcomes did not differ except mortality, which was lower in SFR (1/41, 2.4%) than OB (8/42, 19.0%), p = 0.029.
CONCLUSIONS: Composite outcome of death/NDI at 36 months corrected age was similar; however, reduction in mortality was noted in SFR. This trial was registered 6 Mar 2019 with ClinicalTrials.gov, NCT03867669 ( https://clinicaltrials.gov/search?cond=NCT03867669 ).