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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
Open accessAbstract
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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Successful navigation of this transition facilitates the development of parent-child relationships and helps parents adopt new caregiving roles and skills more swiftly.
“Successful navigation of this transition facilitates the development of parent–child relationships and helps parents adopt new caregiving roles and skills more swiftly (Hei et al. 2016).”
From Experiences and Perceptions of Hospital to Home Transitional Care for Parents of Premature Infants in Neonatal Intensive Care Unit: A Qualitative Meta‐Synthesis (2025) · cites this paper as Hei et al. 2016
The Interventions section describes parents taking on infant-care tasks and attending education sessions to learn caregiving skills; the Background also links parents’ access to the NICU with parent–infant interaction. The paper does not say that successfully navigating a transition develops parent–child relationships or helps parents acquire caregiving roles and skills more swiftly. No page numbers are available in our copy. (LLM, conf=0.82)
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Lu, Q., Liu, X., Shen, Q., Wang, S., & Liu, Z. (2025) · Nursing Open · doi:10.1002/nop2.70387 · Cited by 3
Metadata
- Authors
- Hei, M., Gao, X., Gao, X., Nong, S., Zhang, A., Zhang, Q., & Lee, S. K.
- Affiliations
- Third Xiangya Hospital (CN)
- Xuzhou Medical College (CN)
- Hunan Provincial People's Hospital (CN)
- Shenzhen Maternity and Child Healthcare Hospital (CN)
- Mount Sinai Hospital (CA)
- Corresponding author
- Hei, Mingyan
- Venue
- Trials
- Published
- 2016-01-13
- Volume
- 17
- Issue
- 1
- Pages
- 22-22
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC4711020
- OpenAlex
- W2237238171
- Cited by
- 37
- References
- 0
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 1 · 2023: 5 · 2022: 7 · 2021: 6 · 2020: 4 · 2019: 2 · 2018: 4 · 2017: 2
- FWCI
- 2.69
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- TSpace (University of Toronto) (submittedVersion)
- Funders
- Chinese Medical Board of America (CMB OC 13-162)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Family and Patient Care in Intensive Care Units
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Maternal and Neonatal Healthcare
- Keywords
- family integrated care, neonatal intensive care unit, preterm infants, parent-infant interaction, length of hospital stay, nosocomial infections, breastfeeding, maternal stress, health policy, China
- MeSH terms
- Clinical Protocols, Humans, Infant, Newborn, Infant, Premature, Intensive Care Units, Neonatal, Sample Size, Delivery of Health Care, Integrated
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