Trial reportBMC pediatrics2026
Cluster-randomized evaluation of neonatal intensive care unit quality improvement interventions in extremely preterm infants: secondary analysis of the INTACT trial.
Trial report in BMC pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Neonatal care in a low-birthrate society: insights from population-based observations in Japan.Clinical and experimental pediatrics · 2026Article
- Echocardiographic hemodynamics during early postnatal period and 3-year neurodevelopment outcomes in preterm infants.Pediatric research · 2026Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsWe 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.
resultsIn 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.
conclusionsThis 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.
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