Is family integrated care in neonatal intensive care units feasible and good for preterm infants in China: study protocol for a cluster randomized controlled trial.
Is family integrated care in neonatal intensive care units feasible and good for preterm infants in China: study protocol for a cluster randomized controlled trial.
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DOI：
10.1186/s13063-015-1152-9
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发表时间：
2016-01-13
期刊：
影响因子：
2.5
通讯作者：
Lee SK
中科院分区：
文献类型：
--
作者：
Hei M;Gao X;Gao X;Nong S;Zhang A;Zhang Q;Lee SK
通过改变新生儿重症监护的模式，并将父母纳入护理团队，加拿大开发的“家庭综合护理”（FICare）模式确保婴儿获得更一致的护理，父母能够更好地在新生儿重症监护室（NICU）和家中照顾他们的婴儿。然而，中国的卫生政策规定，父母在婴儿住院期间不允许进入NICU，这抑制了这种类型的父母-婴儿互动，并可能影响婴儿的结局。该项目旨在证明允许父母在NICU中照顾新生儿可以改善婴儿的医疗结果。这项随机对照试验将在中国的6个三级NICU（3个“干预”和3个“对照”NICU）中评估FICare的可行性和有效性。研究步骤为：（1）计划和准备;（2）人员招募和培训;（3）两个中心的初步研究;（4）主要研究的中期分析和样本量确认;（5）主要研究的实施;（6）数据分析和研究报告的编写和发表。主要的结局指标是从入院到出院的住院时间。次要结局指标为：（1）临床结果，如医院感染，（2）体重增加，（3）母乳喂养，（4）完全喂养时间，和（5）母亲压力。本研究将评估FICare在中国的可行性和成本效益。通过建立FICare是中国稳定型早产儿NICU护理的实用模式，该项目将对健康结局、医疗实践和政策以及医疗护理成本产生重大影响。这个项目中使用的方法可以转移到许多其他领域的医疗保健，如儿科，慢性病护理和老年病。该项目的数据可用于为中国新生儿重症监护病房的卫生政策提供信息，以便允许父母进入新生儿重症监护病房，并在婴儿住院期间陪伴在婴儿床边，并修改中国新生儿重症监护病房的设计，以促进父母参与新生儿护理。中国临床试验登记研究ChiCTR-TRC-14004736
By changing the paradigm of neonatal intensive care and integrating parents into the care team, the ‘family integrated care’ (FICare) model developed in Canada ensures that infants receive more consistent care and parents are better able to care for their infants within the neonatal intensive care unit (NICU) and at home. However, Chinese health policy dictates that parents are not allowed into the NICU during their infant’s stay, which inhibits this type of parent–infant interaction and may affect infant outcomes. This project aims to demonstrate that allowing parents to care for their newborn infants in the NICU improves the medical outcomes of infants. This cluster randomized controlled trial will evaluate the feasibility and efficacy of FICare in six Chinese tertiary-level NICUs in China – three ‘intervention’ and three ‘control’ NICUs. The study steps are: (1) planning and preparation; (2) staff recruitment and training; (3) pilot study in two centers; (4) interim analysis and confirmation of sample size for main study; (5) implementation of main study; (6) data analysis and preparation and publication of study reports. The primary outcome measure is duration of hospital stay from admission to discharge. Secondary outcome measures are: (1) clinical outcomes, such as nosocomial infection, (2) weight gain, (3) breastfeeding, (4) time to full feed, and (5) maternal stress. This study will assess the feasibility and cost-effectiveness of FICare in China. By establishing that FICare is a practical model of NICU care for stable preterm infants in China, this project will have a significant impact on health outcomes, medical practice and policy, and the cost of medical care. The approach used in this project could be transferable to many other areas of medical care, such as pediatrics, chronic care, and geriatrics. Data in this project can be used to inform health policy in NICUs across China so that parents are allowed to enter the NICU and be at their infant’s bedside during the baby’s hospitalization, and modifying the design of NICUs in China to facilitate the participation of parents in caring for their newborns. Chinese Clinical Trial Registry ChiCTR-TRC-14004736