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      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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          Abstract

          Background

          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.

          Methods/Design

          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.

          Discussion

          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.

          Trial registration

          Chinese Clinical Trial Registry ChiCTR-TRC-14004736

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          Most cited references18

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          Analysis of cluster randomized trials in primary care: a practical approach.

          Cluster randomized trials increasingly are being used in health services research and in primary care, yet the majority of these trials do not account appropriately for the clustering in their analysis. We review the main implications of adopting a cluster randomized design in primary care and highlight the practical application of appropriate analytical techniques. The application of different analytical techniques is demonstrated through the use of empirical data from a primary care-based case study. Inappropriate analysis of cluster trials can lead to the presentation of inaccurate results and hence potentially misleading conclusions. We have demonstrated that adjustment for clustering can be applied to real-life data and we encourage more routine adoption of appropriate analytical techniques.
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            The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity.

            Parental involvement in the care of preterm infants in NICUs is becoming increasingly common, but little is known about its effect on infants' length of hospital stay and infant morbidity. Our goal was to evaluate the effect of a new model of family care (FC) in a level 2 NICU, where parents could stay 24 hours/day from admission to discharge. A randomized, controlled trial was conducted in 2 NICUs (both level 2), including a standard care (SC) ward and an FC ward, where parents could stay from infant admission to discharge. In total, 366 infants born before 37$$\raisebox{1ex}{$0$}\!\left/ \!\raisebox{-1ex}{$7$}\right.$$ weeks of gestation were randomly assigned to FC or SC on admission. The primary outcome was total length of hospital stay, and the secondary outcome was short-term infant morbidity. The analyses were adjusted for maternal ethnic background, gestational age, and hospital site. Total length of hospital stay was reduced by 5.3 days: from a mean of 32.8 days (95% confidence interval [CI]: 29.6-35.9) in SC to 27.4 days (95% CI: 23.2-31.7) in FC (P = .05). This difference was mainly related to the period of intensive care. No statistical differences were observed in infant morbidity, except for a reduced risk of moderate-to-severe bronchopulmonary dysplasia: 1.6% in the FC group compared with 6.0% in the SC group (adjusted odds ratio: 0.18 [95% CI: 0.04-0.8]). Providing facilities for parents to stay in the neonatal unit from admission to discharge may reduce the total length of stay for infants born prematurely. The reduced risk of moderate-to-severe bronchopulmonary dysplasia needs additional investigation.
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              Individualized developmental care for high risk newborns in the NICU: a practice guideline.

              The newborn infant in the neonatal intensive care unit (NICU) is cared for with highly advanced medical technology, but the incidence of disability and neurodevelopmental problems among survivors remains high and problematic. Preterm birth disrupts the developmental progression of brain structures and affects development of the sensory systems. The Synactive Theory of Development provides a framework to conceptualize the organization of the neurobehavioral capabilities in the early development of the fetus, newborn and young infant. The infant's ability to regulate and control behavior emerges through continued interaction with the environment and is expressed through five systems: autonomic/physiology, motor, state, attention/interaction and self-regulation. In the healthy full term newborn the five subsystems are mature, integrated, synchronized and managed smoothly. The less mature, healthy or sick preterm newborn may be unable or partially able to manage environmental inputs, demonstrating over-reactive responses and poor tolerance from even minimal input. Loss of control and stress responses become frequent unless the environment and caregivers work to read the infants' messages and thresholds for sensitivity and adjust care and handling and the environment based on the infant's behavioral communications. The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) is a comprehensive program which includes a behavioral observation methodology and creation of individual family centered developmental caregiving support of the infant's own developmental goals. The NIDCAP approach seeks to support the infant's stabilization and organization of the autonomic, motor, and state systems at each level of maturation, while minimizing stressful events.
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                Author and article information

                Contributors
                86-731-88618169 , 86-13707313550 , 2533749531@qq.com , heiming_yan@aliyun.com
                g.xy@163.com
                gaoxirong@126.com
                nongsh98@hotmail.com
                lilly610@sina.com
                zhangqianshen2005@163.com
                sklee@mtsinai.on.ca
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                13 January 2016
                13 January 2016
                2016
                : 17
                : 22
                Affiliations
                [ ]Department of Pediatrics, the Third Xiangya Hospital of Central South University, Tongzipo Road 138, Changsha, Hunan 410013 China
                [ ]Department of Pediatrics, Xuzhou Affiliated Hospital of East South University, Xuzhou, Jiangsu 220028 China
                [ ]Department of Neonatology, Hunan Children’s Hospital, Changsha, Hunan 410008 China
                [ ]Department of Pediatrics, Guangdong General Hospital, Guangzhou, Guangdong 510080 China
                [ ]Department of Neonatology, Hunan Provincial People’s Hospital, Changsha, Hunan 410007 China
                [ ]Department of Neonatology, Shenzhen Maternal and Child Healthcare Hospital, Shenzhen, Guangdong 518028 China
                [ ]Department of Pediatrics, Mount Sinai Hospital, University of Toronto, Toronto, Ontario M5G 1X5 Canada
                Article
                1152
                10.1186/s13063-015-1152-9
                4711020
                26758621
                12c097b9-ce17-479f-a29e-3ceff8a740d4
                © Hei et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 28 August 2015
                : 31 December 2015
                Funding
                Funded by: Chinese Medical Board of America
                Award ID: CMB OC 13-162
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Medicine
                cost-effectiveness,family integrated care,neonatal intensive care,newborn,preterm,randomized controlled trial

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