Warm, ventilate, stabilize: Clinical feasibility and non-inferiority study of MINAR™ infant warmer resuscitator

Background: Effective neonatal resuscitation requires integrated thermal support, respiratory assistance, and continuous physiological monitoring. MINAR™, a locally manufactured infant warmer resuscitator developed in Indonesia, was designed to support neonatal stabilization. This study evaluated the clinical feasibility, safety, and non-inferiority of MINAR™ compared with the Dräger Resuscitaire ® . Methods: This single-center, randomized, non-inferiority feasibility trial allocated live-born neonates requiring postnatal resuscitation or stabilization in a 1:1 ratio to MINAR™ or Dräger Resuscitaire ® . Primary outcomes included respiratory rate (RR), heart rate (HR), peripheral oxygen saturation (SpO 2 ), body temperature, Apgar score, and Downes score measured at baseline and 5, 10, 15, and 60 min. Minimum clinically important differences were predefined. Repeated-measures ANCOVA was performed to assess the potential confounding effect of baseline Downes score. Results: Forty-eight neonates were enrolled, and 38 were included in the final analysis (MINAR™, n = 18; Dräger Resuscitaire ® , n = 20). Baseline characteristics were comparable except for a higher baseline Downes score in the Dräger group ( p = 0.004). MINAR™ demonstrated non-inferior performance across all predefined outcomes with no differences exceeding the non-inferiority margins. After adjustment for baseline respiratory distress, MINAR™ remained associated with faster improvement in oxygen saturation and greater reduction in Downes score, whereas RR, HR, body temperature, and Apgar score showed comparable longitudinal trajectories between groups. No device-related adverse events or malfunctions were observed. Conclusions: MINAR™ demonstrated feasibility, safety, and non-inferior clinical performance compared with the Dräger Resuscitaire ® for neonatal postnatal stabilization. The observed advantages in oxygenation and respiratory distress remained independent of baseline respiratory severity, supporting further evaluation in larger multicenter randomized trials. Clinical Trial Registry: ISRCTN88734666