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Family Integrated Care for Preterm Infants in China: A Cluster Randomized Controlled Trial.

  • Hei, Mingyan1
  • Gao, Xiangyu2
  • Li, Ying3
  • Gao, Xirong4
  • Li, Zhankui5
  • Xia, Shiwen6
  • Zhang, Qianshen7
  • Han, Shuping8
  • Gao, Hongxia9
  • Nong, Shaohan10
  • Zhang, Aimin11
  • Li, Jia12
  • Wang, Yanchen13
  • Ye, Xiang Y14
  • Lee, Shoo K15
  • 1 Neonatal Center, Beijing Children's Hospital, Capital Medical University, Beijing, China; National Center of Children's Heath, China. Electronic address: [email protected] , (China)
  • 2 Department of Pediatrics, Southeast University Affiliated Xuzhou Hospital, Xuzhou, Jiangsu, China. , (China)
  • 3 Department of Pediatrics, the Third Xiangya Hospital of Central South University, Changsha, Hunan, China. , (China)
  • 4 Department of Neonatology, Hunan Children's Hospital, Changsha, Hunan, China. , (China)
  • 5 Department of Neonatology, Northwest Women and Children's Hospital, Xi'an, Shaanxi, China. , (China)
  • 6 Department of Neonatology, Hubei Province Women and Children Hospital, Wuhan, Hubei, China. , (China)
  • 7 Department of Neonatology, Shenzhen Maternal and Childcare Hospital, Shenzhen, Guangdong, China. , (China)
  • 8 Depatment of Neonatology, Nanjing Maternity and Child Health Care Hospital, Nanjing, Jiangsu, China. , (China)
  • 9 Department of Neonatology, Gansu Provincial Maternity and Childcare Hospital, Lanzhou, Gansu, China. , (China)
  • 10 Department of Pediatrics, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China. , (China)
  • 11 Department of Neonatology, Hunan Provincial People's Hospital, Changsha, Hunan, China. , (China)
  • 12 Department of Neonatology, Kunming Maternal and Child Healthcare Hospital, Kunming, Yunnan, China. , (China)
  • 13 Chinese Neonatal Network (CHNN), Fudan Children's Hospital, Shanghai, China. , (China)
  • 14 Maternal-infant Care Research Centre, Mount Sinai Hospital, Toronto, ON, Canada. , (Canada)
  • 15 Maternal-infant Care Research Centre, Mount Sinai Hospital, Toronto, ON, Canada; Department of Pediatrics, Mount Sinai Hospital, Toronto, ON, Canada; Department of Pediatrics, University of Toronto Faculty of Medicine, Toronto, ON, Canada. , (Canada)
Published Article
The Journal of pediatrics
Publication Date
Sep 05, 2020
DOI: 10.1016/j.jpeds.2020.09.006
PMID: 32898578


To explore whether Family Integrated Care (FICare) is feasible and improves the outcomes of preterm infants in China. This was a multicenter prospective cluster-randomized controlled trial comparing FICare and standard care. Primary outcome was length of stay (LOS). Secondary outcomes were nosocomial infections, duration of supplemental oxygen, breastfeeding, and weight gain. Outcomes were compared using univariate and multivariable analyses adjusted for potential confounders and clustering. We enrolled 601 preterm infants from 11 neonatal intensive care units (FICare, n=298; control, n=303). Unadjusted LOS was 30.81 vs 30.26 days (mean ratio 1.02, 95% CI 0.85-1.22; P = .85). After adjustment, outcomes in the FICare group were improved compared with the control group, including: LOS (28.26 vs 35.04 days; mean ratio 0.81, 95% CI 0.72-0.91), total medical expenditures (mean ratio 0.69, 95% CI 0.53-0.90), weight gain velocity (15.73 vs 10.30 g/day; mean difference 5.43, 95% CI 3.65-7.21), duration of supplemental oxygen (13.11 vs 21.42 days; mean difference 0.71, 95% CI 0.50-1.00), nosocomial infection rates (4.13 vs 5.84/1000 hospital days; mean ratio 0.67, 95% CI 0.47-0.96), antibiotic exposure (38.63 vs 57.32/100 hospital days; mean ratio 0.67, 95% CI 0.47-0.96), breastfeeding rates (87.25% vs 55.78%; OR 5.42, 95% CI 3.25-9.05), and re-hospitalization rates (3.65% vs 7.48%; OR 0.47, 95% CI 0.28-0.77). At follow-up to 18 months, breastfeeding rates and weight were significantly (p<0.05) higher over time in the FICare group. FICare was feasible in Chinese neonatal intensive care units and reduced the duration of hospitalization, medical expenditures and rates of adverse outcomes. Copyright © 2020. Published by Elsevier Inc.

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