Evidence map›Paper›PMID 26758621›Full record

Trial reportTrials2016

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.

Mingyan Hei, Xiangyu Gao, Xirong Gao, Shaohan Nong, Aimin Zhang, Qianshen Zhang, Shoo K Lee

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 38 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 2 countries.

Mingyan HeiDepartment of Pediatrics, the Third Xiangya Hospital of Central South University, Tongzipo Road 138, Changsha, Hunan, 410013, China. 2533749531@qq.com.
Xiangyu GaoDepartment of Pediatrics, Xuzhou Affiliated Hospital of East South University, Xuzhou, Jiangsu, 220028, China. g.xy@163.com.
Xirong GaoDepartment of Neonatology, Hunan Children's Hospital, Changsha, Hunan, 410008, China. gaoxirong@126.com.
Shaohan NongDepartment of Pediatrics, Guangdong General Hospital, Guangzhou, Guangdong, 510080, China. nongsh98@hotmail.com.
Aimin ZhangDepartment of Neonatology, Hunan Provincial People's Hospital, Changsha, Hunan, 410007, China. lilly610@sina.com.
Qianshen ZhangDepartment of Neonatology, Shenzhen Maternal and Child Healthcare Hospital, Shenzhen, Guangdong, 518028, China. zhangqianshen2005@163.com.
Shoo K LeeDepartment of Pediatrics, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, M5G 1X5, Canada. sklee@mtsinai.on.ca.
Central South University · CNGuangdong General Hospital · CNHunan Children's Hospital · CNHunan Provincial People's Hospital · CNShenzhen Maternity and Child Healthcare Hospital · CNUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBy 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/

designThis 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 registrationChinese Clinical Trial Registry ChiCTR-TRC-14004736.

Indexed as

Clinical ProtocolsDelivery of Health Care, IntegratedIntensive Care Units, NeonatalHumansInfant, NewbornInfant, PrematureSample Size

Identifiers

PMID26758621
PMCPMC4711020
OpenAlexW2237238171

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.