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Randomized Trial of Perfusion-Based Circulatory Management in Infants of Very Low Birth Weight
Akio Ishiguro1, Ayumi Sasaki1, Yukiko Motojima1
1Division of Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine, Saitama Medical Center, Saitama Medical University, Kawagoe, Saitama, Japan.
Insights
Blood flow (BF)-based management did not significantly reduce intraventricular hemorrhage (IVH) in very low birth weight (VLBW) infants compared to blood pressure (BP)-based methods. However, low BF showed a correlation with IVH, suggesting potential for optimized BF strategies.
Area of Science:
- Neonatalogy
- Pediatric Cardiology
- Critical Care Medicine
Background:
- Intraventricular hemorrhage (IVH) is a significant concern in very low birth weight (VLW) infants.
- Conventional management relies on blood pressure (BP)-based strategies.
- Blood flow (BF)-based management offers a potential alternative for preventing IVH.
Purpose of the Study:
- To compare the efficacy of BF-based circulatory management versus BP-based management in preventing IVH in VLBW infants.
- To investigate the relationship between BF, BP, and IVH incidence.
Main Methods:
- A randomized trial involving VLBW infants assigned to either BF-based or BP-based management.
- Primary outcome was the incidence of IVH.
- Secondary analysis compared IVH rates among healthy infants and those responsive or unresponsive to intervention.
Main Results:
- The incidence of IVH was not significantly different between the BF group (6.8%) and the BP group (10.9%).
- Low BF was significantly correlated with a higher incidence of IVH (aOR 3.24), while low BP was not.
- IVH incidence was significantly higher in VLBW infants with unsuccessful BF intervention compared to healthy infants.
Conclusions:
- The current BF management protocol did not significantly reduce IVH incidence in VLBW infants.
- Optimized BF-based strategies may hold promise for future IVH prevention.
- BF monitoring may be a more sensitive indicator for IVH risk than BP monitoring in VLBW infants.
Objective:
To establish the superiority of blood flow (BF)-based circulatory management over conventional blood pressure (BP)-based management strategies used for preventing intraventricular hemorrhage (IVH) in infants of very low birth weight (VLBW).
Study Design:
We conducted a nonblinded, single-centered randomized trial with the aim to prevent IVH by managing BF. Infants with VLBW were assigned randomly to a BF-based group or BP-based (BP group) circulatory management group. The incidence of IVH was the outcome of interest. The IVH also data were compared among healthy patients and patients responsive and unresponsive to the intervention.
Results:
A total of 219 and 220 infants with VLBW were assigned to the BF and BP groups, respectively. The IVH incidence rate was lower in the BF group, but the difference was not statistically significant (BF group, 6.8% vs BP group, 10.9%; P = .14). In 21% of patients of the BP group and 20% of the BF group, the intervention failed. In BF group, the IVH incidence rate was significantly greater in infants with unsuccessful intervention when compared with healthy individuals (6% vs 23%, P = .001). Multivariate logistic regression analysis revealed a correlation between low blood flow and IVH (aOR 3.24; 95% CI 1.49-7.08, P = .003) but not between low BP and IVH (P = .73).
Conclusions:
The BF management protocol did not significantly decrease the incidence of IVH. However, after further optimization, we speculate the treatment strategy holds promise in decreasing the incidence of IVH. Trial registration UMIN-CTR: UMIN000013296.
