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Updated: Jan 13, 2026
Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Cluster-randomized evaluation of neonatal intensive care unit quality improvement interventions in extremely preterm
Katsuaki Toyoshima1, Rintaro Mori2, Toshihiko Nishida3
1Department of Neonatology, Kanagawa Children's Medical Center, 2-138-4 Mutsukawa, Minami-Ku, Yokohama, 232-8555, Japan. nqf37179@nifty.com.
Insights
A quality improvement (QI) program in neonatal intensive care units (NICUs) reduced acute morbidities in extremely preterm infants. While survival without neurodevelopmental impairment was not improved, the QI intervention shows promise for improving acute outcomes in NICU settings.
Area of Science:
- Neonatal Intensive Care
- Quality Improvement Science
- Clinical Trial Research
Background:
- The INTACT trial evaluated a multidisciplinary quality improvement (QI) program in neonatal intensive care units (NICUs).
- The program did not improve survival without neurodevelopmental impairment at 3 years in very low birthweight infants.
- Further evaluation of the QI program's effect on acute outcomes in extremely preterm infants is warranted.
Purpose of the Study:
- To assess the effect of the INTACT study's QI intervention on acute morbidities during NICU stay.
- To evaluate the impact of the QI intervention on outcomes at 3 years of age.
- To analyze the QI program's effectiveness in extremely preterm infants (gestational age < 28 weeks).
Main Methods:
- Secondary analysis of a cluster-randomized controlled trial (INTACT) involving 40 Japanese NICUs (2012-2014).
- Infants stratified into gestational age groups: 22-24 weeks and 25-27 weeks.
- Primary outcome: composite of seven acute morbidities; Secondary outcomes: chronic morbidities and 3-year outcomes. Multivariable logistic regression and Holm's correction were used.
Main Results:
- In the 25-27-week subgroup, the QI intervention group had significantly lower composite acute morbidity (31.3% vs. 40.3%; aOR 0.67).
- In the 22-24-week subgroup, sepsis (aOR 0.44) and pulmonary hemorrhage (aOR 0.27) were significantly reduced.
- No significant differences in neurodevelopmental outcomes at 3 years were observed between groups after adjustment.
Conclusions:
- A NICU-specific QI program based on participatory learning reduced acute-phase morbidities in infants born between 22 and 27 weeks of gestation.
- Findings suggest the potential for widespread clinical implementation of such QI programs in neonatal intensive care.
- QI interventions may improve acute outcomes for extremely preterm infants during their NICU stay.
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.
