Original Investigation
Pediatrics
April 9, 2025
Multimodal Monitoring of Hemodynamics in Neonates With Extremely Low Gestational Age: A Randomized Clinical Trial
Renjini Lalitha, Eyad Bitar, Matthew Hicks, et al
JAMA Netw Open. 2025;8(4):e254101. doi:10.1001/jamanetworkopen.2025.4101
Question Does multimodal hemodynamic assessment during the transitional period (first 72 hours of life) improve cardiorespiratory-kidney health at 7 days in neonates with extremely low gestational age (<29 weeks’ gestation)?
Findings In this randomized clinical trial of 132 neonates with extremely low gestational age, multimodal hemodynamic assessment in the first 72 hours of life compared with standard hemodynamic assessment using mostly clinical-biochemical data did not clearly improve cardiorespiratory-kidney health at 7 days of life, as suggested by the mean vasoactive-ventilation-renal scores (16.5 vs 18.9).
Meaning Multimodal hemodynamic assessment in the transitional period may have little to no effect on cardiorespiratory-kidney health at 7 days in neonates with extremely low gestational age.
Abstract
Importance Evaluation and treatment of transitional circulation in neonates with extremely low gestational age (ELGA) varies greatly across centers.
Objective To determine whether multimodal hemodynamic monitoring in neonates with ELGA during the transitional period (first 72 hours of life) will improve cardiorespiratory-kidney health by decreasing vasoactive-ventilation-renal (VVR) score at 7 days.
Design, Setting, and Participants This unmasked, 2-arm randomized clinical trial included neonates born at a gestational age of 230 to 286 weeks and admitted to a neonatal unit in Canada. Patients were enrolled from February 15, 2019, to December 31, 2021, with follow-up completed in April 2022.
Interventions Neonates in the multimodal arm received early targeted neonatal echocardiography at 18 to 24 and 66 to 72 hours of life and cerebral near-infrared spectroscopy (NIRS) for the first 72 hours. A study guideline incorporating clinical-biochemical and cerebral near-infrared spectroscopy data was used for hemodynamic consultation in the multimodal arm. Neonates in the standard arm received hemodynamic assessment using clinical-biochemical data.
Main Outcome and Measures The primary outcome was VVR score at 7 days. The VVR score incorporates measures of inotrope use, ventilation support, and kidney function to reflect cardiorespiratory-kidney health, with possible scores ranging from 0 to 69.62 at 7 days; higher scores indicate worse cardiorespiratory-kidney health.
Results Primary analysis included 132 neonates with ELGA (68 in the multimodal arm and 64 in the standard arm) with mean (SD) gestational age of 26.4 (1.5) weeks (75 [56.8%] male). The mean (SD) VVR score at 7 days was 16.5 (15.4) in the multimodal arm and 18.9 (20.2) in the standard arm (P = .45). A day 7 peak VVR score greater than 53 (>95th percentile for VVR in the entire cohort) was seen only in the standard arm (7 of 63 [11.1%] vs 0 in the multimodal arm; P = .005) and was associated with a composite outcome of death or severe intraventricular hemorrhage (odds ratio [OR], 12.37; 95% CI, 1.92-79.63; P = .001) and bronchopulmonary dysplasia (BPD) (6 of 6 [100%] vs 55 of 116 [47.4%]; P = .01). Incidence of BPD was lower in the multimodal arm (26 of 63 [41.3%] vs 36 of 61 [59.0%]; P = .04). Logistic regression showed that VVR score at 7 days in the top quartile (adjusted OR [AOR], 11.40; 95% CI, 2.04-63.67), late sepsis (AOR, 65.24; 95% CI, 5.70-748.18), and patent ductus arteriosus treatment after 72 hours of life vs early or no treatment needed (AOR, 7.20; 95% CI, 1.60-32.41) were associated with BPD.
Conclusions and Relevance In this study of neonates with ELGA, multimodal hemodynamic assessment was not associated with decreased VVR scores at 7 days. However, this approach led to lower incidence of VVR associated with severe adverse outcomes and lower BPD incidence, suggesting further investigation is needed.
Trial Registration ClinicalTrials.gov Identifier: NCT03841929
