Background: Simulation education is a bridge between classroom learning and real-life clinical experience. It helps in nursing competency before engaging in real situation with the newborns to enhance safety. Aim: This study aimed to evaluate the effect of integrated high-fidelity simulation on self-efficacy and satisfaction of pediatric nursing students regarding newborn assessment. Research design: A quasi-experimental design was utilized in the current study. Setting: This study was conducted at Clinical Pediatric Laboratory Skills for third year students and teaching hall of Faculty of Nursing, Benha University. Subjects: A convenient sample of all pediatric nursing students who were studying the pediatric nursing course was enrolled in the study (254 students). Tools of data collection: Four tools were used: Tool (1): A structured interviewing questionnaire; Part (1): Personal characteristics of the studied students, Part (2): Pediatric nursing students' knowledge regarding newborn assessment. Tool (2): Observational checklist for newborn assessment. Tool (3): Self-efficacy regarding newborn assessment. Tool (4): Students' satisfaction. Results: Showed that most of the studied students had unsatisfactory level of knowledge and practice and had low self-efficacy at pre simulation intervention. Compared with, high self-efficacy at immediate post and after four weeks simulation intervention. Conclusions: High fidelity simulation intervention regarding newborn assessment had a significant positive effect in improving students' knowledge, practice, self-efficacy and satisfaction towards newborn assessment. Recommendations: Integration of high fidelity simulation in pediatric nursing program to enhance students' acquisition of knowledge and performance.