Journal Article

Cluster-randomized evaluation of neonatal intensive care unit quality improvement interventions in extremely preterm infants: secondary analysis of the INTACT trial

Shimokaze, Tomoyuki, Saito, Tomoko, Kusuda, Satoshi, Sasaki, Hatoko, Mori, Rintaro, Mitsuhashi, Hideko, Toyoshima, Katsuaki, Kono, Yumi, Uchiyama, Atsushi, Fujimura, Masanori, Nishida, Toshihiko, Yonemoto, Naohiro, Aoki, Hirosato

2026

Overview

Background The Improvement of Neonatal Intensive Care Unit (NICU) Practices and Team Approach Cluster-randomized Controlled Trial (INTACT) tested a multidisciplinary quality improvement (QI) program but did not show improved survival without neurodevelopmental impairment at 3 years among infants with very low birthweight. However, the program’s potential effect on acute-phase outcomes in extremely preterm infants (< 28 weeks of gestation) warrants further evaluation. This secondary analysis aimed to assess the effect of the INTACT study’s QI intervention based on participatory learning and action on acute morbidities during the NICU stay and outcomes at 3 years of age. Methods We performed a secondary analysis of data from the INTACT trial, a cluster-randomized controlled trial conducted in 40 Japanese NICUs from 2012–2014. Infants were stratified into two gestational age groups (22–24 weeks and 25–27 weeks). The primary outcome was a composite of seven acute morbidities (pulmonary air leak syndrome, pulmonary hemorrhage, sepsis, severe intraventricular hemorrhage, intestinal perforation, necrotizing enterocolitis, or circulatory collapse) between the intervention (QI program) and control groups. Secondary outcomes included chronic morbidities diagnosed before NICU discharge and long-term outcomes at 3 years of age. Multivariable logistic regression and Holm’s correction for multiple comparisons were applied. Results In the 25–27-week subgroup, the intervention group showed a significantly lower rate of composite acute morbidity than the control group (31.3% vs. 40.3%; adjusted odds ratio [OR] 0.67; 95% confidence interval 0.50–0.90; p  = 0.008). In the 22–24-week subgroup, composite acute morbidity did not differ significantly; however, sepsis (adjusted OR: 0.44, Holm-adjusted p  = 0.010) and pulmonary hemorrhage (adjusted OR: 0.27, Holm-adjusted p  = 0.028) were significantly reduced. After multivariable adjustment and Holm correction, no differences in neurodevelopmental outcomes at 3 years of age were observed between groups. Conclusions This secondary analysis of a cluster-randomized controlled trial demonstrated that the intervention group receiving a NICU-specific QI program had reduced acute-phase morbidities, particularly among infants born between 22 and 27 weeks of gestation. Our findings highlight the potential for widespread clinical implementation of QI programs based on participatory learning and action in neonatal intensive care.

• Publisher: BioMed Central,BioMed Central Ltd,BMC
• Subject: Analysis / Care and treatment / Child, Preschool / Evidence-based medicine / Female / Gestational Age / Humans / Infant, Extremely Premature / Infant, Newborn / Infant, Premature, Diseases - prevention & control / Infant, Premature, Diseases - therapy / Infants (Premature) / Intensive Care Units, Neonatal - standards / Internal Medicine / Japan / Male / Medical care / Medicine / Medicine & Public Health / Morbidity / Neonatal care / Neonatal intensive care / Pediatric health disparities: addressing inequities in access and outcomes / Pediatric research / Pediatrics / Pregnancy / Prematurity / Pulmonary Hemorrhage / Quality control / Quality Improvement / Quality management / Sepsis