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. 2016 Jan 13;17:22. doi: 10.1186/s13063-015-1152-9

Fig. 1.

Fig. 1

Flow chart of study design. This is a cluster randomized control trial about family integrated care (FICare) in China. This 3-year research is divided into two stages: an internal pilot study (1 year) and a main study (2 years). Ethical approval will be obtained first, followed by recruitment of research collaborator. After basement data collection, six level III NICUs in different tertiary hospitals will be randomly divided into two groups: the FICare group and the control group. Questionnaires about the demands of and attitude to FICare, and recruitment lectures about FICare will be completed in the early stage of the internal pilot study. A small number of patients will be enrolled in the internal pilot study. The data in the internal pilot study will be used to re-adjust the final sample size. Primary outcome measure data and secondary outcome measure data will be collected in both the internal pilot study and the main study. Data will be statistically analyzed at the end of the whole study