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BackgroundWe have developed a Family Integrated Care (FIC) model for use in a neonatal intensive care unit (NICU) where parents provide most of the care for their infant, while nurses teach and counsel parents. The objective of this pilot prospective cohort analytic study was to explore the feasibility, safety, and potential outcomes of implementing this model in a Canadian NICU.MethodsInfants born ≤35 weeks gestation, receiving continuous positive airway pressure or less respiratory support, with a primary caregiver willing and able to spend ≥8 hours a day with their infant were eligible. Families attended daily education sessions and were mentored at the bedside by nurses. The primary outcome was weight gain, as measured by change in z-score for weight 21 days after enrolment. For each enrolled infant, we identified two matched controls from the previous year’s clinical database. Differences in weight gain between the two groups were analyzed using a linear mixed effects multivariable regression model. We also measured parental stress levels using the Parental Stress Survey: NICU, and interviewed parents and nurses regarding their experiences with FIC.ResultsThis study included 42 mothers and their infants. Of the enrolled infants, matched control data were available for 31 who completed the study. The rate of change in weight gain was significantly higher in FIC infants compared with control infants (p < 0.05). There was also a significant increase in the incidence of breastfeeding at discharge (82.1 vs. 45.5%, p < 0.05). The mean Parental Stress Survey: NICU score for FIC mothers was 3.06 ± 0.12 at enrolment, which decreased significantly to 2.30 ± 0.13 at discharge (p < 0.05). Feedback from the parents and nurses indicated that FIC was feasible and appropriately implemented.ConclusionsThis study suggests that the FIC model is feasible and safe in a Canadian healthcare setting and results in improved weight gain among preterm infants. In addition, this innovation has the potential to improve other short and long-term infant and family outcomes. A multi-centre randomized controlled trial is needed to further evaluate the efficacy of FIC in the Canadian context.

• Pain at the time of vaccine injection is a common concern and contributes to vaccine hesitancy across the lifespan.• Evidence-based and feasible interventions are available to mitigate pain and are part of good vaccination clinical practice.• This guideline includes recommendations for pain mitigation based on five domains of pain management interventions (procedural, physical, pharmacologic, psychological and process): the "5P" approach.

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BackgroundAdmission to the neonatal intensive care unit (NICU) may disrupt parent-infant interaction with adverse consequences for infants and their families. Several family-centered care programs promote parent-infant interaction in the NICU; however, all of these retain the premise that health-care professionals should provide most of the infant’s care. Parents play a mainly supportive role in the NICU and continue to feel anxious and unprepared to care for their infant after discharge. In the Family Integrated Care (FICare) model, parents provide all except the most advanced medical care for their infants with support from the medical team. Our hypothesis is that infants whose families complete the FICare program will have greater weight gain and better clinical and parental outcomes compared with infants provided with standard NICU care.Methods/DesignFICare is being evaluated in a cluster randomized controlled trial among infants born at ≤ 33 weeks’ gestation admitted to 19 Canadian, 6 Australian, and 1 New Zealand tertiary-level NICU. Trial enrollment began in April, 2013, with a target sample size of 675 infants in each arm, to be completed by August, 2015. Participating sites were stratified by country, and by NICU size within Canada, for randomization to either the FICare intervention or control arm. In intervention sites, parents are taught how to provide most of their infant’s care and supported by nursing staff, veteran parents, a program coordinator, and education sessions. In control sites standard NICU care is provided. The primary outcome is infants’ weight gain at 21 days after enrollment, which will be compared between the FICare and control groups using Student’s t-test adjusted for site-level clustering, and multi-level hierarchical models accounting for both clustering and potential confounders. Similar analyses will examine secondary outcomes including breastfeeding, clinical outcomes, safety, parental stress and anxiety, and resource use. The trial was designed, is being conducted, and will be reported according to the CONSORT 2010 guidelines for cluster randomized controlled trials.DiscussionBy evaluating the impact of integrating parents into the care of their infant in the NICU, this trial may transform the delivery of neonatal care.Trial registrationNCT01852695, registered December 19, 2012