NeoNatalie Versus NeoNatalie Live Simulation for Training Undergraduate Students in Neonatal Resuscitation-A Randomized Control Trial.

Background: The most used manikin for neonatal resuscitation training is NeoNatalie (N), a low-fidelity manikin. A new manikin, NeoNatalie Live (NL), has been developed with more fidelity. We completed a noninferiority RCT to evaluate skill acquisition and to assess retention after 4 months of using these manikins. Methodology: Performance evaluation test (PET), a 14-item checklist, was used to assess students' skills before and after training and after 4 months. The maximum score was 100, and the noninferiority limit was 5. One hundred forty-three medical students were assigned randomly into two groups: N (n = 72) and NL (n = 71). Half of each group was evaluated on a simulator different from the one they were trained on. Results: Mean (SD) pretest PET scores (before training) for the NL and N groups were comparable across groups (39.5 [18.15] vs. 34.8 [19.10]; p = 0.13). The PET score was comparable between NL and N after training (82.46 [10.28] vs. 80.52 [13.07], absolute difference 1.93; 95% CI [-1.956343, 5.830363]; p = 0.83 [1-sided]). NL was statistically noninferior to N as the lower bound of 95% CI of absolute difference is greater than the noninferiority margin (-1.95 > -5). A similar finding was observed in retention after 4 months (76.09 [15.80] vs. 73.33 [18.42]; absolute difference 2.75; 95% CI [-2.92457, 8.43271], p = 0.83 [1-sided]). The mean gain of PET score within the group (posttest minus pretest) for NL and N was comparable (42.97 [17.11] vs. 45.73 [19.51]; absolute difference 2.76; 95% CI [-8.835228, 3.306668], p = 0.81 [1-sided]). Conclusion: There was an improvement in scores in the posttest for both manikins. The NL was noninferior as compared to N.