MANUSCRIPT CITATION

O’Brien K, Robson K, Bracht M, Cruz M, Lui K, Alvaro R, da Silva O, Monterrosa L, Narvey M, Ng E, Soraisham A, Ye XY, Mirea L, Tarnow-Mordi W, Lee SK; FICare Study Group and FICare Parent Advisory Board. Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial. Lancet Child Adolesc Health. 2018 Apr;2(4):245-254. PMID: 30169298.

REVIEWED BY

Kathleen E Hannan, MD
University of Colorado

Stephanie L Bourque, MD, MSCS
University of Colorado

TYPE OF INVESTIGATION

Treatment

QUESTION

In a population of neonates born at 33 weeks’ gestation or earlier, does a Family Integrated Care (FICare) model compared to standard NICU care affect infant weight gain at 21 days, breastfeeding frequency, parental stress and anxiety, infant mortality, major neonatal morbidities, duration of oxygen therapy, and length of hospital stay?

METHODS

• Design: Multicenter, cluster-randomized controlled trial
• Allocation: Not concealed
• Blinding: Unblinded
• Follow-up period: The primary outcome of weight gain was assessed at 21 days after enrollment. Morbidities were assessed through the infants’ birth hospitalization.
• Setting: This study took place in 25 NICUs throughout Canada, Australia, and New Zealand
• Patients:
  • Eligible infants included those born before or at 33 weeks’ gestation and who were on no or low-level respiratory support, defined as oxygen by cannula or mask, or non-invasive ventilation. Parents in the FICare group committed to being present in the NICU for at least 6 hours per day, to attend educational sessions, and to actively care for their infant. Centers that were eligible for the study included units that agreed to provide educational resources for families and nurses if randomly assigned to receive the intervention, provide families with a rest space and sleep rooms for the exclusive use of parents, comfortable reclining chairs at bedside, free parking or transport vouchers, and nurses with FICare training in preparation for the study.
  • Infants who excluded were those receiving palliative care, having a major life-threatening congenital anomaly, critical illness or those who were deemed unlikely to survive, requiring high-level respiratory support (invasive ventilation), scheduled for early transfer to another hospital, or born to parents unable to participate because of health, social, or language barriers.
• Intervention: Sites randomzied to the intervention group participated in the FICare model. A team from each FICare intervention site attended a 2-day training workshop focused on implementation of a parent education program with small group education sessions, parent coaching at the bedside, parent involvement in medical rounds, tools for NICU staff to mentor, coach, and support parents, policies, procedures, and environmental resources to operationalize parent invovlement, and a program of psychosocial support for families while admitted to the NICU.
• Outcomes:
  • The primary outcome was infant weight gain (measured by change in weight Z score) at 21 days after enrollment.
  • Secondary outcomes included weight gain velocity (at enrollment, day 7, day 14, and day 21), high-frequency breastfeeding at hospital discharge (defined as 6 or more feeds per day at the breast), parent stress and anxiety at enrollment and day 21, NICU mortality and major neonatal morbidities, duration of oxygen therapy, length of hospital stay, and incident reports of adverse events.
• Analysis and Sample Size:
  • Analysis was by intention to treat.
  • There were 14 sites randomized to the FICare intervention group, with 3012 patients assessed for eligibility. Among those eligible, 895 were enrolled, all were included in intention-to-treat analysis. 12 sites randomized to the stardard care group, with 2015 pateints assessed for eligibility. Among those eligible, 891 enrolled and all were included in the intention-to-treat analysis.
• Patient follow-up: % included in analysis: Among enrolled infants, all were included in the analysis.

MAIN RESULTS

The FICare and standard care groups had similar distribution of infant sex, birthweight, and mean weight at enrollment. A greater percentage of infants in the FICare group were lower gestational age and of Caucasian race, whereas a higher percentage of infants in the standard care group were singletons. Other infant and maternal characteristics were similar between the groups.

Primary outcome:

Infants in the FICare group demonstrated better weight gain at 21 days, compared to infants in the standard care group with mean change in weight Z score of -.071 compared to -0.155 (p<0.01). The difference in weight Z score remained significant after adjustment for covariates and after sensitivity analysis. Infants in the FICare group also had higher mean daily weight gain (26.7g vs. 24.8g, p<0.01) and percent change in weight at 21 days (42.6% vs 38.9%, p<0.01).

Secondary outcomes:

Rate of high-frequency breastfeeding (>6 times per day) was higher in the FICare group compared to the standard care group (70% vs 63%, p=0.02), however infants receiving any breastmilk at discharge was higher in the standard care group compared to the FICare group (81% vs. 75%, p=<0.01).

At enrollment, total stress and anxiety scores among parents were similar between groups. Mean scores decreased in both groups at day 21, however the mean stress and anxiety scores for parents in the FICare group were significantly lower than those for parents in the standard care group (stress score 2.3 vs. 2.5, p<0.01, anxiety score 70.8 vs. 74.2, p<0.01).

There were no significant differences between groups in the secondary outcomes of neonatal mortality or major morbidities, duration of oxygen therapy, and hospital length of stay. No adverse events attributable to FICare were reported during the trial.

CONCLUSION

In this cluster randomized controlled trial, the authors show that infants receiving FICare had improved weight gain in the NICU at 21 days post-intervention, increased high-frequency breastfeeding, and decreased levels of parental stress and anxiety. There was no difference in mortality or major neonatal morbidities, and no adverse events associated with the implementation of FICare were reported.

COMMENTARY

Family involvement in the NICU is known to improve infant outcomes and parental mental health (1,2).  Studies have examined single care interventions such as kangaroo care(3), however, structured and comprehensive approaches for integrating family as primary caregivers during infant admission have not been formally studied.

This study evaluates a comprehensive program, the Family Integrated Care (FICare) model, on several short-term infant and parental outcomes through a multicenter, cluster randomized-controlled trial (RCT). Infants in the FICare group demonstrated improved weight gain, higher rates of high-frequency breastfeeding, and lower parental stress and anxiety, compared to the standard care group. They found no significant differences for infant mortality, major neonatal morbidities, duration of oxygen therapy, or hospital length of stay.

This was a well-designed and carefully thought-out RCT. A major strength is inclusion of 25 centers across 3 countries, allowing for increased generalizability. Most previous studies examining care-by-parent programs were in low- and middle-income settings often with overall lower NICU acuity(1,4). Further, this study population included a wider range of preterm infants from 22 to 33 weeks gestational age (GA). The intervention was also a multi-layer model, including a comprehensive program of parental education, facilitated engagement, and nursing support. Previous studies have shown the importance of particular elements of family-centered care in the ICU such as family presence and support for families(5), however optimizing direct care by families at the bedside is a novel approach.

There were several limitations to this study. The primary outcome of weight gain was recorded at 21 days post-enrollment and was not analyzed at later time points. Although optimal growth velocity has been associated with improved neurodevelopmental outcomes, there is little evidence on the persistent effects of short-term weight gain in the NICU (5). Biases including different centers with different practices, patient populations, and staff may have contributed to the results, either positively or negatively. Given the strict requirement of parental involvement for >6 hours/day, eligible families likely had different resources than ineligible families and although the authors attempted to address this through a sensitivity analysis, it is unlikely that this accounted for all confounders.

Despite these limitations, this RCT provides novel information on the positive impact of family engagement in the NICU on important infant and parental outcomes. The benefits and barriers to involving families in the care of their infant in the NICU have been well described(6), and this study supports that despite being resource-intensive, FICare is a specific and feasible approach. We feel that both previous qualitative studies and these RCT data indicate that this model improves the outcomes of some of our most vulnerable neonates.  The feasibility of implementing FICare may be difficult for units with space constraints and most certainly requires adaptations in how bedside providers interact with families. More work is also needed to evaluate longer term effects, such as neurodevelopmental progress, hospital readmissions, and family dynamics post-NICU stay, however this study provides encouraging evidence of the importance of integrating families into the medical care of neonates in the NICU.

REFERENCES

1. Bhutta ZA, Khan I, Salat S, Raza F, Khan I, Ara H. Reducing length of stay in hospital for very low birthweight infants by involving mothers in a stepdown unit : an experience from Karachi (Pakistan). BMJ. 2004;329:1151–5.
2. Melnyk BM, Feinstein NF, Alpert-gillis L, Fairbanks E, Crean HF, Sinkin RA, et al. Reducing Premature Infants ’ Length of Stay and Improving Parents ’ Mental Health Outcomes With the Creating Opportunities for Parent Empowerment (COPE) Neonatal Intensive Care Unit Program: A Randomized, Controlled Trial. Pediatrics. 2006;118(5).
3. Conde-Agudelo A, Diaz-Rossello J. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants (Review). Cochrane Database Syst Rev. 2016;(8).
4. Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, et al. The Stockholm Neonatal Family Centered Care Study : Effects on Length of Stay and Infant Morbidity. Pediatrics. 2010;125(e278).
5. Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, et al. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017;45(1):103–28.
6. Gooding JS, Cooper LG, Blaine AI, Franck LS, Howse JL, Berns SD. Family Support and Family-Centered Care in the Neonatal Intensive Care Unit : Origins , Advances , Impact. Semin Perinatol [Internet]. 2011;35(1):20–8. Available from: http://dx.doi.org/10.1053/j.semperi.2010.10.004