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Neonatal outcomes from a quasi-experimental clinical trial of Family Integrated Care versus Family-Centered Care for preterm infants in U.S. NICUs

Abstract

Background

Family Integrated Care (FICare) benefits preterm infants compared with Family-Centered Care (FCC), but research is lacking in United States (US) Neonatal Intensive Care Units (NICUs). The outcomes for infants of implementing FICare in the US are unknown given differences in parental leave benefits and health care delivery between the US and other countries where FICare is used. We compared preterm weight and discharge outcomes between FCC and mobile-enhanced FICare (mFICare) in the US.

Methods

In this quasi-experimental study, we enrolled preterm infant (≤ 33 weeks)/parent dyads from 3 NICUs into sequential cohorts: FCC or mFICare. Our primary outcome was 21-day change in weight z-scores. Our secondary outcomes were nosocomial infection, bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), and human milk feeding (HMF) at discharge. We used intention-to-treat analyses to examine the effect of the FCC and mFICare models overall and per protocol analyses to examine the effects of the mFICare intervention components.

Findings

253 infant/parent dyads participated (141 FCC; 112 mFICare). There were no parent-related adverse events in either group. In intention-to-treat analyses, we found no group differences in weight, ROP, BPD or HMF. The FCC cohort had 2.6-times (95% CI: 1.0, 6.7) higher odds of nosocomial infection than the mFICare cohort. In per-protocol analyses, we found that infants whose parents did not receive parent mentoring or participate in rounds lost more weight relative to age-based norms (group-difference=-0.128, CI: -0.227, -0.030; group-difference=-0.084, CI: -0.154, -0.015, respectively). Infants whose parents did not participate in rounds or group education had 2.9-times (CI: 1.0, 9.1) and 3.8-times (CI: 1.2, 14.3) higher odds of nosocomial infection, respectively.

Conclusion

We found indications that mFICare may have direct benefits on infant outcomes such as weight gain and nosocomial infection. Future studies using implementation science designs are needed to optimize intervention delivery and determine acute and long-term infant and family outcomes.

Clinical Trial Registration

NCT03418870 01/02/2018.

Peer Review reports

Introduction

Parent contributions to the care and outcomes of preterm infants admitted to Neonatal Intensive Care Units (NICU) is undisputed [1,2,3,4]. Family-centered care (FCC) is a term used to describe a set of principles that assert the central role families (parents or other primary caregivers) have in promoting the health and development of critically ill infants receiving intensive care and guide the relationship between healthcare professionals and family caregivers [3]. FCC is also an umbrella term used to describe models of NICU care where parents are active partners in shared decision-making and direct caregiving for their infant [1]. NICUs with care delivery models based on FCC principles promote specific parent-delivered interventions, such as breastfeeding, skin-to-skin contact, developmentally-supportive care, positive sensory stimulation, pain management and massage. These practices lead to improved outcomes for preterm infants and families [1]. However, full parental partnership care and decision-making remains an elusive goal in most NICUs [1, 5]. It also remains unclear what ‘dose’ of FCC practices and parental involvement are necessary for optimal infant outcomes. Moreover, there are likely disparities in parental involvement based on parental and NICU resources [6].

The Family-Integrated Care (FICare) model has emerged as a well-defined yet flexible model of parent-partnered NICU care that has been shown to improve infant and parent outcomes in clinical trials and quality improvement evaluations across high- and middle-income countries and levels of neonatal care [7,8,9,10,11,12,13,14,15]. FICare has four main pillars: NICU environment, NICU team education and support, parent education, and parent support [16]. Clinical trials have demonstrated improved weight gain [9,10,11], breastfeeding at discharge [9,10,11], shorter lengths of stay [9, 10, 12, 13], and lower rates of sepsis [10, 13] for infants in FICare versus FCC NICUs. Longer-term outcomes include better mental and psychomotor development at 18 months for infants from FICare versus FCC NICUs [8, 10, 14].

There are fundamental differences between United States (US) health and social care systems and those of other countries that might impact FICare feasibility and outcomes. Families in the United States (US) have less access to statutory paid parental leave benefits than most countries [17], severely curtailing their participation in caregiving during prolonged NICU hospitalization. US families also may have greater healthcare administrative and cost burden (e.g., obtaining information, referrals, insurance authorizations, billing issues, and out-of-pocket expenses) [18]. Notably, the published FICare research to date has been conducted outside the US.

Mobile technology has been proposed to enhance FICare delivery by providing parents with greater access to educational content and encouragement, as well as promoting partnership between parents and NICU staff [12]. Mobile technology may also aid in the research process by improving participant data collection efficiency and experience. Therefore, we aimed to investigate the effects of a mobile-enhanced FICare (mFICare) program in US NICUs. We hypothesized that infants whose parents participated in mFICare would have greater weight gain and fewer morbidities than infants whose parents received usual FCC. We also examined mFICare program components to determine their differential effects on infant outcomes.

Methods

Design

In planning for this study, we first engaged extensively with parents of current and former NICU patients and with NICU healthcare professionals to tailor the FICare intervention to the local setting and to develop and pilot a mobile app for parents [19]. We then conducted a quasi-experimental, time-lagged intervention trial (NCT03418870; 01/02/2018), in which we prospectively enrolled infant/parent dyads into one of two sequential cohorts. This design was chosen because it was impossible to individually randomize the intervention without significant risk of spillover and contamination of the study groups. The first cohort included six sites where all infants and families received usual FCC. After completion of enrolment of the FCC cohort, we paused recruitment for mFICare training of NICU staff and parent mentors. Once training was completed, we enrolled the second cohort of parent/infant dyads to participate in the mFICare program because only three sites secured funding to participate in the mFICare cohort. This analysis compares infant outcome for the usual FCC and mFICare cohorts at those three sites.

Sample size estimate

The sample size for our main infant outcome, change in weight z-score, was established for our primary site, and other sites were experimental and included for feasibility and acceptability evaluation and to increase representativeness [19]. For the primary site, with a projected 100 participants, 20% attrition (80 participants after attrition), a standard deviation in infant weight z-scores of 0.44–0.47 [11], and a two-tailed t-test with conventional alpha 0.05, we estimated 80% power to detect a group difference of 0.28 to 0.29. Since we included the additional sites in our analysis, and adjusted for site, we expected to be able to detect a slightly smaller effect size than this.

Setting

The three sites included one level IV NICU with single and double family rooms in a university health system (Site A), one level IV NICU in a free-standing children’s hospital with three large open-bay rooms (Site B), and one large level III NICU in a community hospital with many small and large open bay rooms across 2 floors (Site C). All NICUs were regional centers providing care to infants from ethnically diverse urban and rural communities. Sites A and C provided high-risk maternity care with NICUs serving both inborn and outborn neonates, whereas Site B served outborn neonates only. Sites B and C primarily served neonates whose families had publicly funded health insurance or were without coverage, whereas Site A served more families with private health insurance. The NICUs provided FCC as their standard model of NICU care and encouraged 24/7 parental/primary caregiver presence.

Participants

Parents/primary caregivers of infants born at ≤ 33 weeks gestation were invited to participate and give consent for their infant’s participation. Parent/infant dyads were excluded if: (1) the parent was not English literate, < 18 years of age, or had no smart phone or tablet access; or (2) the infant had a life-threatening congenital anomaly or was receiving palliative care. For multiple births, the primary parent self-identified as spending the most time in the NICU and the primary infant was selected by random assignment. If a second parent met eligibility criteria and wanted to participate, they were assigned the second infant (by random assignment if triplets or quadruplets). Parents of eligible infants were approached about study enrollment early in the NICU admission, but given that the initial days and sometimes weeks of a NICU stay are typically a stressful time for families, they also had the option to defer until a later time, as long as the infant was expected to remain in the NICU for a minimum of 21 days. In addition, outborn infants may have been enrolled later, depending on their age at admission to the study site. Parents received up to $50 in gift cards for completion of study surveys. The study was approved by the institutional review boards at each site and written informed consent was obtained from all parents.

Intervention

Details of usual FCC and mFICare model components are provided in Table 1. Briefly, parents/infants enrolled in the FCC group received standard NICU care that included a supportive physical and interpersonal environment. Parents were encouraged to spend extended periods in the NICU with their infant. The environment varied by site, but all included reclining chairs, family lounges, kitchens, locked personal storage, Wi-Fi access, and breast pumps. All sites provided NICU orientation for parents and written and video materials to support parent knowledge, skill-building, and coping. Individualized parent teaching and support were delivered bedside by nurses, discharge coordinators, or other specialists, and in a discharge class (sites B and C). Parents were encouraged to participate in infant care under nursing supervision for feeding, bathing, dressing, and holding skin-to-skin. Individualized support was also provided by social workers, developmental specialists, lactation consultants, physical therapy, occupational therapy, or other specialists. Participants also received instruction on using We3health™ Tracker, an app co-designed by parents to document time spent with their infant, infant caregiving, observations, learning needs and skills acquisition.

Table 1 Comparison of Family-Centered Care (FCC) and mobile-enhanced Family-Integrated Care (mFICare)

After completion of enrollment for the FCC group, the study was paused for two to three months at each site so the study team could provide in-person and online training to the volunteer “mFICare nurse champions” and alumni parent peer mentors. Additionally, approximately 80% of all other NICU nurses, nurse practitioners, physicians, therapists, and social workers received in-person and online in-service education specific to their roles. The training followed the Canadian FICare staff curriculum [20, 21].

After completion of training, parents and infants were enrolled in the mFICare group. In addition to all the FCC supports and services described above, the mFICare group received: parent group educational classes 2–5 times per week, following the Canadian FICare parent curriculum, with additional classes added based on local site interests [20, 21]; additional encouragement and expanded role for parents in direct infant caregiving (excluding ventilation management, intravenous fluid or intravenous medication administration); parent participation in weekday rounds; parent peer mentorship and an expanded version of the We3health™ app designed for the mFICare group (Table 1).

Measures

Our primary infant outcome was the change in weight z-scores over the 21 days after study enrollment (study days 1 to 22). Weights on study day 29 and at discharge were also collected for sensitivity analyses. Weights were obtained from the infant medical record, and z-scores were calculated to standardize weights against gestational age-based norms [22]. A z-score change of zero indicates that an infant’s weight has a consistent percentile rank over time relative to preterm infant growth norms, change values greater than zero indicate an increasing percentile rank (i.e., weight gain that is faster than age-based norms), and change values less than zero indicate a decreasing percentile rank (i.e., weight gain that is slower than age-based norms).

Secondary infant outcomes included in this analysis were three common preterm morbidities recorded in the discharge summary (nosocomial infection, bronchopulmonary dysplasia [BPD], or retinopathy of prematurity [ROP]) and not receiving human milk feeds (HMF) at discharge. Information on the infant’s clinical course was collected from their medical records. We also recorded any adverse events involving parents in both cohorts.

mFICare intervention fidelity was monitored monthly to ensure that all families assigned to the mFICare group were being offered the opportunity to participate in each of the mFICare components. Monthly fidelity monitoring involved the research team documenting parent being offered and participating in different components of the mFICare intervention: acceptance of a peer mentor, degree of participation in weekday rounds (based on direct observation or information collected from the infant’s nurse), attendance at group classes (recorded by class facilitator), and use of the mFICare app. Results were regularly discussed with all NICU stakeholder groups (nursing, medicine, parent advisors, NICU leadership) within and across participating NICUs, and additional education, coaching, improvements to procedures and resource materials were provided at all sites throughout the project.

Statistical analysis

Analyses were performed using R v4.1 (R Foundation, Vienna, Austria) and Stata v14.2 (StataCorp, College Station, TX). Descriptive statistics were calculated and comparisons by intervention group were performed using chi-square tests for categorical variables, analysis of variance for normally distributed continuous variables, and Mann-Whitney or Kruskal-Wallis tests for non-normally distributed continuous variables. For these group comparisons, p < 0.05 was considered statistically significant.

We compared 21-day change in weight z-scores between the 2 groups over the 3-week study period (change in z-scores measured on study days 1, 8, 15, and 22, using a linear mixed model with LME4 v1.1.27.1), testing an interaction term between group and post-baseline weight measurements [23]. We adjusted for additional covariates using a hybrid approach, forcing in known confounders of gestational age and study site and using backwards stepwise selection to retain covariates that contributed p < 0.1 to the final model from potential confounders. We additionally conducted sensitivity analyses adding in weights measured at study day 29, and at discharge.

Second, we conducted a per protocol analysis of 21-day change in weight z-scores, evaluating the intervention dose effects of 4 mFICare components during the same 21-day study period: whether the enrolled parent had a mentor; participated in weekday rounds (trichotomized: no dose (< 10%), low dose [10–79%], or high dose [≥ 80%]); attended group classes (trichotomized: no dose [0 classes], low dose [< 1/week], or high dose [≥ 1/week]; or regularly used the We3health™ app (trichotomized: no dose [< 1/week], low dose [1–3/week], or high dose [≥ 4/week]).

Third, we conducted intent-to-treat and per protocol analyses of the mFICare intervention effects on the secondary outcomes: nosocomial infection, BPD, ROP, and no HMF at discharge. We used logistic regression for these analyses because the secondary outcomes were dichotomous. We used the same procedure for inclusion of covariates as before, except that we did not include nosocomial infection, BPD or ROP as potential confounders (as they were now outcomes). For these secondary outcomes, which spanned the entire hospitalization, we used the mFICare intervention dose from enrollment to discharge.

mFICare group assignment and participation in the individual intervention components served as the reference groups for all regression analyses so that the statistical results highlight the increased risk of adverse outcomes with usual FCC compared with mFICare (rather than the decreased risk with mFICare compared with usual FCC). For the intention-to-treat analysis of our primary outcome, we used p < 0.05 for statistical significance, and for the secondary outcomes, we used a Bonferroni-corrected p < 0.0125. For the per protocol analysis, we noted results with a nominal p < 0.05, as none reached Bonferroni-corrected significance. Additional sensitivity analyses were conducted to evaluate the impact of including infants who were transferred to another hospital before being discharged home (n = 27); or infants who were hospitalized during the initial months of the COVID-19 pandemic (n = 26).

Results

Sample characteristics

Participants were enrolled between April, 2017 and June, 2020. The final sample included 253 infants (Fig. 1).

Fig. 1
figure 1

Participant enrollment by group

Table 2 summarizes infant characteristics by intervention group. There were no significant differences in sample characteristics, length of stay or outcomes at discharge by intervention group. COVID-19 related hospital restrictions partially curtailed the intervention for 23% (n = 26) of the mFICare group. These infants did not differ from the rest of the sample on any characteristics in Table 2. In sensitivity analyses, only one finding was attenuated by their exclusion (described below). Additional sensitivity analyses indicated that including infants transferred to another hospital before being discharged home had minimal impact on study findings (data not shown). No parent-related adverse events related were reported in either group.

Table 2 Infant characteristics by intervention group (N = 253)

Intervention doses

All mFICare group participants were offered a parent mentor, participation in weekday clinical team rounds, weekly group classes, and unlimited use of the We3health™ mFICare version app. However, parents varied in their use of each intervention component. The frequencies of dose levels of each component are summarized in Table 3. Data collected through the app on parental presence and skin-to-skin care were found to be inconsistent among parents and over time. Some parents used the app daily; some used it initially, then decreased use over time; and some used it once or twice and then didn’t engage any further, despite encouragement. Given the inconsistent documentation of the parental presence and skin-to-skin data by parents or by staff in the electronic medical records, these data were not included in the analysis. In addition, based on input from parent advisors during the study planning and considering the often informal nature of parent mentoring (e.g., phone, text, email, social media chat), the amount of contact between participating parents and their mentors was not recorded.

Table 3 Doses of four intervention components for the 112 participants in the mFICare group

Primary outcome: weight gain

Intention-to-treat: The final model indicated that 21-day change in weight z-scores did not differ by intervention group (Fig. 2; Table 4). To determine whether intervention effects required more than 3 weeks to emerge, we performed sensitivity analyses to model infant weight change over a 4-week study period (study day 1 to 29) and from enrollment to discharge, but no differences by intervention group were found (data not shown).

Fig. 2
figure 2

Weight gain by intervention group and mFICare component (paired with a parent mentor, participation in weekday rounds; adjusted for covariates). Bars are based on the linear mixed model, and error bars represent standard error; *indicates significantly more weight gain (P < 0.05); NS, not significant (P > 0.05)

Table 4 Intention-to-treat evaluation of infant outcomes by intervention group

Per protocol analysis of intervention components: Infants whose parents had not been paired with a parent mentor or attended 11 or fewer clinical team rounds during the 3-week study period lost nominally more weight relative to age-based norms than infants whose parents had a mentor or attended ≥ 12 rounds (mentor group difference = -0.128, 95% CI: -0.227, -0.030; 0–1 vs. ≥12 rounds group difference = -0.084, 95% CI: -0.154, -0.015; 0–1 rounds group difference = 0.061, 95% CI: -0.018, 0.141; 2–11 vs. ≥12 rounds group difference = -0.146, 95% CI: -0.237, -0.055; Fig. 2; Table 5). The effect of rounds was attenuated if parents affected by COVID-19 related hospital restrictions (including discontinuation of in-person and remote parent participation on rounds) were excluded from the analysis (data not shown).

Table 5 Per protocol analysis of intervention components

Secondary outcomes: morbidities and human milk feeding

Morbidities: The odds of acquiring a nosocomial infection were 2.6 times higher in the usual FCC group compared with the mFICare group, adjusting for relevant covariates (OR = 2.6, 95% CI: 1.0, 6.7; p < 0.05; Fig. 3), but none of the other morbidities differed by intervention group (Table 4). Infants of parents who participated in 0–1 clinical team rounds during their hospitalization had 2.9 times higher odds of acquiring a nosocomial infection (OR = 2.9, 95% CI: 1.0, 9.1; p < 0.05; Table 5; Fig. 3) than infants of parents who participated in two or more clinical team rounds. Infants whose parents did not participate in any group classes had 3.8 times higher odds of acquiring a nosocomial infection (OR = 3.8, 95% CI: 1.2, 14.3, p < 0.05; Table 5; Fig. 3) than infants of parents who participated in any of the group classes.

Fig. 3
figure 3

Infection rates by intervention group and mFICare component (participation in weekday rounds and group educational classes; marginal mean effects adjusted for covariates), and error bars represent standard error. *Significantly lower risk than standard care (FCC) or not receiving intervention component

Feeding: To determine whether the mFICare intervention had any impact on HMF at discharge, regression models were fit to assess the associations between intervention variables (study group and dose of each mFICare component) and the infant not being discharged on HMF. The proportion of infants not receiving HMF at discharge did not differ by intervention group (Table 4) or by use of any mFICare intervention component (data not shown).

Discussion

In this quasi-experimental study to investigate the effects of the mFICare program compared to usual FCC in US NICUs on infant clinical outcomes, our intention-to-treat analyses showed that infant weight gain did not differ between groups. However, we found that infants in the usual FCC group had 2.6 times higher odds of acquiring nosocomial infection during their NICU stay than infants in the mFICare group. In our per protocol analyses, we found that if parents engaged in the mFIcare program as indicated by being paired with a parent mentor and/or regularly participating in rounds, infants had improved weight gain by 21 days after enrollment compared to if their parents had not been paired with a parent mentor or had not participated in weekday rounds. Similarly, we also found that when parents engaged in the mFICare program by participating in rounds or classes, infants had between approximately 2.9 or 3.8 times lower odds of acquiring a nosocomial infection compared to if their parent had not participated in at least 2 weekday rounds or at least one group class during the 3-week study period, respectively. These results suggest that the mFICare program may have beneficial effects on infant clinical outcomes. While acknowledging the importance of the interaction and mutual reinforcement of the program components, our results provide a preliminary indication that parental engagement in mentorship, parent participation in clinical team rounds, and parent group classes, showed promise for improving infant outcomes in this study. Further research will be needed.

Previous studies have found decreased infection rates in infants receiving FICare compared with FCC [10, 13]. Studies have demonstrated the benefits to patient care quality and safety of including parents as active members in clinical rounds [24] and providing parents with knowledge and emotional/practical support through individual peer parent mentorship and group support/education [25, 26]. FICare is a model of NICU care delivery designed to support greater parent engagement in the care of their infant in the NICU. The improved infant outcomes found in previous studies are attributed to the increased parent engagement across the continuum of caregiving and shared decision-making, not to any specific component of the program itself. It is challenging for bedside care providers to record parent participation in care, and even the use of a mobile app to support parents recording their own participation was incomplete. However, our research team collected detailed information from nurses on how often parents were present in rounds, how often they attended education sessions and how many were connected with parent mentors as measures of model fidelity. Although participation in these activities as part of mFICare is likely mutually reinforcing, the differential effects in our study suggest that parents may have distinct needs or preferences for different types of involvement or support. Engagement of parents as full partners in their infant’s healthcare is visibly demonstrated through their active inclusion in rounds where their infant’s clinical progress is reviewed, and care plan decisions are made. We speculate that these FICare components may impact infant outcomes through activation of parents in infant caregiving, particularly with respect to developmental care for infants [27, 28], and greater knowledge and assertiveness, specifically regarding hygiene and feeding [29]. Of note, we did not find a specific effect of the mobile app on infant outcomes, as was previously reported [12]. However, the We3health™ app may have contributed indirectly by increasing parent participation in other FICare activities (e.g., rounds, classes, mentor contact). Finally, no adverse events related to parental participation in mFICare were reported. Future studies are needed to confirm these findings in the US context and further explore mechanisms of action.

In contrast to the previous multi-site cluster randomized trial of the FICare program [11], we found no intervention group effect on either weight gain or HMF compared with usual FCC care. This may be due to differing inclusion criteria, with the infants in our study being overall smaller, sicker, more racially/ethnically diverse, and more likely to be outborn, and their parents becoming involved in the mFICare program later in the NICU stay. Infants in our study also required more surgery, ventilatory support, and feeding support at discharge than the prior international trial. It is also possible that we did not achieve a sufficient dose of the mFICare intervention, or succeed in increasing parents’ active participation in caregiving, because we did not require parents to be present in the NICU for a minimum number of hours per weekday as in the previous trial. We also were unable to provide parents at all sites with free parking, transportation, or childcare for siblings during parents’ time in hospital, which may have curtailed their mFICare participation. Moreover, FCC practices at all three of the study sites were well developed, with many of the environmental and staff knowledge and attitude practices in place [28]. Thus, the main differences between the intervention and usual care groups were the components of parent mentorship, participation in rounds and parent group education as well as in the consistency of tracking and monitoring parental engagement in their infant’s care.

Our study contributes to the growing research on the benefits of supporting and partnering with parents of preterm and ill infants. Our study is unique in the level of detail we captured on parental participation in the main mFICare components, allowing us to identify the components that most likely influenced the selected outcomes. Although our approach of analyzing the individual components of the mFICare bundle may overestimate their impact if they were to be implemented separately, it does provide a preliminary indication of which components are most strongly associated with which outcomes and what might be a minimal effective level of engagement for each. These findings provide crucial implementation guidance to clinical teams, such as which elements of the intervention bundle they may want to emphasize first or where to focus quality improvement efforts to promote parental engagement. Nonetheless, future research is needed to determine if there is a dose effect of the number of rounds a parent participates in or the number of classes they attend, as well as the relative importance of specific class content (e.g., developmental care) [27, 28]. These findings can inform implementation strategies to enhance fidelity, quality, and dose of the mFICare components in future research and quality improvement initiatives.

Our study had several limitations in design and implementation. First, there may be selection bias because of the non-random design. Although we observed no demographic or clinical differences between the groups, unmeasured changes in parental presence, parent support, or clinical practices during the two enrollment periods could have influenced the outcomes. Second, not all families in the mFICare group received the full intervention dose. This may be due to inconsistencies in mFICare practices across large staff groups at the three sites, despite offering extensive training and support, as well as enrollment later in the hospital admission (or after transfer from another NICU). Individual parent circumstances and preferences, particularly with respect to financial or social barriers, likely limited some parents’ participation. Thus, the negative findings of the intention-to-treat analyses may be due to insufficient intervention delivery rather than the intervention’s lack of impact. Moreover, family presence, participation in infant caregiving and decision-making and family support services were all curtailed by the hospitals’ responses to the COVID-19 pandemic, reducing intervention dose for some participants. Third, the study excluded non-English-speaking families, limiting generalizability. Finally, we examined only a few possible infant outcomes and future longitudinal follow-up studies are needed as FICare’s greatest impact may occur after discharge in improved infant neurodevelopment and parent mental health [8, 10].

Despite the limitations, we successfully delivered the mFICare program to a racially/ethnically diverse cohort of families in three types of NICUs serving different populations. Our research highlights the need for improvement in hospital data systems to do a better job in aggregating information on parental presence and involvement in caregiving and decision-making for research and quality improvement purposes. Unfortunately, most hospital clinical data systems are poorly designed to accurately collect and aggregate data on parental presence and involvement. Despite substantial nursing time spent documenting such activities, the inconsistency in documentation locations, terminology and missingness mean that the data are of poor quality. Redesign of hospital information systems and integration of available technology are urgently needed to address the data gaps, reduce nursing data entry burden and improve usability of data on parent presence and participation in caregiving and decision-making. Design of apps for parents must also be improved to reduce parent data entry burden and improve positive feedback to encourage ongoing involvement and parenting skill acquisition and mastery.

Further research of the FICare model is needed, using implementation science methods [30] to address the barriers and bottlenecks to FICare implementation in the US context. This includes greater focus on structural barriers to parental presence and active involvement in their infant’s care, addressing paid family leave, childcare for siblings, costs of transportation, parking, food, overnight accommodation, and other out-of-pocket expenses. Institutional barriers to transforming the NICU culture to one that fully supports and promotes full parental partnership in care include staff education, attitudes and beliefs, power hierarchy, and workload [5, 31]. Until these structural issues are addressed, neither FCC nor mFICare will achieve their full potential to improve infant and family outcomes.

In summary, we found promising indications that mFICare may have direct benefits on infant outcomes such as weight gain and nosocomial infection. Future research using implementation science designs are needed to optimize intervention delivery and determine acute and long-term infant and family outcomes.

Availability of data and materials

Deidentified data will be shared upon reasonable request directed to Linda S. Franck (linda.franck@ucsf.edu) from qualified investigators beginning 6 months and ending 5 years after publication.

Abbreviations

BPD:

Bronchopulmonary Dysplasia

FCC:

Family-Centered Care

FICare:

Family Integrated Care

mFICare:

mobile-enhanced Family Integrated Care

NICU:

Neonatal Intensive Care Unit

ROP:

Retinopathy of Prematurity

US:

United States

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Acknowledgements

The authors are grateful for the support of the research team from each site, all the staff and parents who participated in the research and for the valuable partnership of the UCSF California Preterm Birth Initiative Parent Clinician Advisory Board.

Funding

University of California, San Francisco, California Preterm Birth Initiative, funded by Marc and Lynne Benioff.

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Authors and Affiliations

Authors

Contributions

LF conceptualized and designed the study, drafted the initial manuscript, and reviewed and revised the manuscript. RK coordinated data acquisition, conducted data curation and provided project administration and critically reviewed the manuscript for important intellectual content. CD, PJ, RB contributed to conceptualization of the study, supervised data collection, and critically reviewed the manuscript for important intellectual content. CG and TH carried out the analyses and critically reviewed the manuscript for important intellectual content. BL and YS contributed to conceptualization and intervention design and critically reviewed the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Linda S. Franck.

Ethics declarations

Ethics approval and consent to participate

All study procedures were performed in accordance with the Declaration of Helsinki and were approved by the Institutional Review Boards at the University of California, San Francisco (16-19542) and participating hospitals. Written informed consent was obtained from all parents/legal guardians for their participation and that of their child.

Consent for publication

N/A.

Competing interests

The authors declare that they have no competing interests.

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Franck, L.S., Gay, C.L., Hoffmann, T.J. et al. Neonatal outcomes from a quasi-experimental clinical trial of Family Integrated Care versus Family-Centered Care for preterm infants in U.S. NICUs. BMC Pediatr 22, 674 (2022). https://doi.org/10.1186/s12887-022-03732-1

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Keywords

  • Family partnerships
  • Infant
  • Neonatology
  • Weight gain
  • Nosocomial infection
  • Peer mentors
  • Clinical rounds
  • Parent education