Family Integrated Care for Preterm Infants in China: A Cluster Randomized Controlled Trial



To explore whether Family Integrated Care (FICare) is feasible and improves the outcomes
of preterm infants in China.

Study design

This was a multicenter prospective cluster-randomized controlled trial comparing FICare
and standard care. Primary outcome was length of stay (LOS). Secondary outcomes were
nosocomial infections, duration of supplemental oxygen, breastfeeding, and weight
gain. Outcomes were compared using univariate and multivariable analyses adjusted
for potential confounders and clustering.


We enrolled 601 preterm infants from 11 neonatal intensive care units (FICare, n=298;
control, n=303). Unadjusted LOS was 30.81
vs 30.26 days (mean ratio 1.02, 95% CI 0.85-1.22;
P = .85). After adjustment, outcomes in the FICare group were improved compared with
the control group, including: LOS (28.26 vs 35.04 days; mean ratio 0.81, 95% CI 0.72-0.91),
total medical expenditures (mean ratio 0.69, 95% CI 0.53-0.90), weight gain velocity
(15.73 vs 10.30 g/day; mean difference 5.43, 95% CI 3.65-7.21), duration of supplemental
oxygen (13.11 vs 21.42 days; mean difference 0.71, 95% CI 0.50-1.00), nosocomial infection
rates (4.13 vs 5.84/1000 hospital days; mean ratio 0.67, 95% CI 0.47-0.96), antibiotic
exposure (38.63 vs 57.32/100 hospital days; mean ratio 0.67, 95% CI 0.47-0.96), breastfeeding
rates (87.25% vs 55.78%; OR 5.42, 95% CI 3.25-9.05), and re-hospitalization rates
(3.65% vs 7.48%; OR 0.47, 95% CI 0.28-0.77). At follow-up to 18 months, breastfeeding
rates and weight were significantly (p<0.05) higher over time in the FICare group.


FICare was feasible in Chinese neonatal intensive care units and reduced the duration
of hospitalization, medical expenditures and rates of adverse outcomes.

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