Extracorporeal membrane oxygenation in term newborns. A prospective cost-benefit analysis.

Clinicians reserve ECMO for neonates at >; 80% predicted mortality risk. The authors hypothesized that ECMO instituted at lower (50%) mortality risk would result in fewer intensive care unit days and a lower hospital cost compared with conventional therapy (including ECMO at high mortality risk). This was a randomized control trial, cost-benefit analysis in an academic newborn intensive care unit. The patients were a prospectively studied, consecutive sample of 41 term neonates with 1) age 24-72 hours, 2) "maximal medical management" for > 6 hours, 3) oxygenation index (OI) values > 25 but < 40. (Severity of illness measured by OI = ((mean airway pressure x FiO2 x 100) PaO2)). All eligible patients entered. Thirty-two of 37 survivors were evaluated at 1 year. Intervention occurred when OI = 25. Patients were randomized to ECMO or continued medical management (ECMO possible at OI = 40). Planned primary outcome measures were ICU days and hospital charges. Secondary measures were pulmonary and neurologic outcomes at discharge and 1 year. Twenty-two early ECMO patients, 19 controls, 14/19 met late ECMO criteria. Four patients died (two each group). No statistically significant difference was seen in hospital charges (early ECMO = $49,500 versus control = $53,7000), (95% confidence intervals = -$3200 to +$5100 more for controls) or ICU days (early = 14 + 5 days versus control = 19 + 12 days) (95% CI = -0.8 to +10 more for controls). At 1 year the early group had a higher mental developmental index score (115 + 11) versus (103 + 18), (p = 0.07).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes