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Controlled Clinical Trial
. 2022 Nov 22;22(1):674.
doi: 10.1186/s12887-022-03732-1.

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

Linda S Franck  1 , Caryl L Gay  2 , Thomas J Hoffmann  3 , Rebecca M Kriz  2 , Robin Bisgaard  4 , Diana M Cormier  5 , Priscilla Joe  6 , Brittany Lothe  7 , Yao Sun  8
Affiliations
Controlled Clinical Trial

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

Linda S Franck et al. BMC Pediatr. .

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.

Keywords: Clinical rounds; Family partnerships; Infant; Neonatology; Nosocomial infection; Parent education; Peer mentors; Weight gain.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Participant enrollment by group
Fig. 2
Fig. 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)
Fig. 3
Fig. 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
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References

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