Family Integrated Care, an intervention where parents helped provide support to their infants in the NICU, helped improved infant weight gain versus standard NICU care, Canadian researchers reported.
Infants randomized to Family Integrated Care (FICare) had a significantly greater weight gain at day 21 compared with infants receiving standard care (mean change in Z scores 1.58 versus 1.45, respectively, P<0.0001), according to Karel O'Brien, MB, of Sinai Health System in Toronto, and colleagues.
Moreover, parents in the FICare group had significantly lower mean stress scores (2.3 versus 2.5, respectively, P<0.00043) and anxiety scores (70.8 versus 74.2, respectively, P=0.0045), they wrote in the Lancet Child & Adolescent Health.
They noted that “care-by-parent” NICU models revealed such short-term benefits, such as improved infant weight gain, decreased nosocomial infection, fewer readmissions, and improved breastfeeding rates. Despite this research, “most [programs] do not integrate parents as part of the care team,” they said.
This multi-center trial randomized 18 tertiary NICUs from Canada, six from Australia, and one from New Zealand to either provide FICare or standard NICU care. Infants born ≤33 weeks gestation who had no or low-level respiratory support — defined as oxygen by cannula or mask or non-invasive ventilation such as continuous positive airway pressure, biphasic CPAP, and nasal intermittent pressure ventilation — were eligible to participate.
Families in the FICare sites had to commit to having a primary caregiver at the infant’s bedside for a minimum of 6 hours per day, 5 days a week, and to attend “medical rounds and education” for at least 3 weeks. They were then “encouraged to participate in care and orientated to the resources and tools available for education, charting and participation on rounds.” As part of the program, these parents bathed, fed, provided skin-to-skin care, dressed, changed diapers, and administered oral medications for their infants.
Overall, 13 NICUs provided FICare (one of 14 discontinued due to poor enrollment) and 12 provided standard care. There were 895 infants eligible for the FICare group and 891 eligible for the standard care group. Age of enrollment was similar between the two groups, although the authors noted that a larger portion of infants in the FICare group were born between 22 and 28 weeks versus the usual care group, and more parents in that group self-identified as Caucasian.
The difference in infant weight gain between the two groups was significant, even after adjusting for confounders, and the authors said that weight gain in the FICare group “increased faster and remained higher” during 21 days.
Parental stress scores were assessed via the Parental Stressor Scale: NICU and the State Trait Anxiety Inventory. Baseline scores between the two groups were similar, and both were lower on day 21, but the FICare group had significantly lower stress and anxiety scores versus the standard care group.
Rates of exclusive breastfeeding were also significantly higher in the FICare group, based on the rate of high-frequency breast milk feeds, defined as more than 6 times a day, compared with the standard care group (70% versus 63%, respectively, P=0.016).
But there were no differences between groups in rates of mortality, major morbidity, duration of oxygen therapy or duration of hospital stay, even after adjusting for confounders.
An accompanying editorial by Chris Gale, PhD, of Imperial College London sounded a couple of notes of caution, with the caveat that randomized trials must “identify and treat” comparison groups equally, based on the outcome of interest. He added that the FICare group required “considerable commitment,” and may have played a role in the results.
“The degree to which unmeasured confounders explain the differences seen in the study outcomes, rather than FICare per se, might be considerable, particularly in relation to parent-reported stress and anxiety,” Gale argued.
He also added that “it is not clear how [the primary outcome of weight gain after 21 days enrollment] relates to long-term measures of infant development or well-being, highlighting the importance of identifying core outcomes for neonatal trials that are important to stakeholders, including parents and ex-neonatal patients.”
O’Brien’s group noted limitations independent of the study design, such as increased rates of transfer of infants from FICare sites to level 2 NICUs before discharge home, and that there was less information about the status of infants in the FICare group than about infants in the standard care group upon discharge home. They also said they did not report the difference in weight gain at 36 weeks and at discharge home between infants in both groups because “some data were missing.”
The study was funded by the Canadian Institutes of Health Research (CIHR) Partnerships for Health System Improvement and the Ontario Ministry of Health and Long-Term Care.
O’Brien and one co-author disclosed grants from CIHR and Ontario Ministry of Health and Long-Term Care. One co-author disclosed a relevant relationship with the ALPHA Collaboration.
Gale disclosed a relevant relationship with the ALPHA Collaboration.
F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner