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

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.DiscussionThis 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

Parental readiness for hospital discharge as a mediator between quality of discharge teaching and parental self‐efficacy in parents of preterm infants

“…In this way, parents have enough time and opportunity to learn to care for their infants under guidance. In China, parents have few chances to learn at bedside due to the NICU's no visitation policy (Hei et al, 2016). In addition, the high patient-nurse ratio and nurses' heavy workload further limit nurses' time for discharge teaching.…”

Factors Affecting Breastfeeding Outcomes at Six Months in Preterm Infants

“…Management of neonatal intensive care units (NICUs) in China continues to face many difficulties and challenges, and many factors impede the implementation of BF among preterm infant-mother dyads. Most of the Chinese NICUs still use the separation policy or traditional care model, where parents are not allowed to enter the unit during the infant's hospitalization and mother-infant reunion occurs only when the infant is ready for discharge (Hei et al, 2016). This NICU care model is related to the concerns over infection control, policy, and protocols as well as the shortage of well-trained health providers.…”

Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial

“…A new model of care, Family Integrated Care (FICare), shows promise as an intervention to improve outcomes for early preterm infants cared for in Level III NICUs [ 38 – 40 ]. Based on these promising results, FICare is being evaluated in two cluster randomized controlled trials (cRCTs): one is a 26-site international (Canada, Australia, New Zealand) trial [ 41 ], and one a 6-site trial in China [ 42 ]. Another Canadian study using a pre-test/post-test design in Level II NICUs is currently in progress.…”