Research Appraisals
Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.
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European journal of pediatrics
Evaluating the impact of simulation on patient outcomes in pediatric and neonatal critical care: a systematic review and critical appraisal of the evidence
UNLABELLED: While the literature widely supports a positive relationship between simulation-based education (SBE) and learning outcomes, its impact on patient outcomes remains less clearly understood. Our aim was to comprehensively survey the landscape of simulation-based research (SBR) that evaluates patient outcomes (Kirkpatrick Level 4) in the context of pediatric and neonatal critical care. A systematic search of MEDLINE, Cochrane Library, CINAHL, and ERIC was conducted through December 2024. We included RCTs, non-RCTs, and before-after studies focusing on Kirkpatrick Level 4 outcomes. Quality was appraised using the RoB 2 and ROBINS-I tools. A total of 2481 articles were screened. Sixteen studies met the inclusion criteria. Most were prospective (63%) and single-center (69%), with only three RCTs (19%). All included studies (100%) reported Level 4 outcomes; however, a critical distinction emerged between system-level and patient-level results. While 75% (12/16) of studies reported positive impacts on Level 4a (system processes), such as protocol adherence or response times, only 50% (8/16) demonstrated significant improvements in Level 4b (direct patient outcomes), such as mortality or complication rates. In addition, all included studies were judged to have a high or critical risk of bias. CONCLUSIONS: Although SBE effectively optimizes clinical processes (Level 4a), a significant evidence gap remains regarding its direct impact on patient health (Level 4b). Current SBR often lacks the methodological rigor-specifically the use of randomized designs-needed to isolate SBE as the primary driver of clinical improvement. Future research must prioritize high-quality, multicenter trials targeting patient-oriented metrics to bridge this translational gap. WHAT IS KNOWN: • SBE has been extensively developed in pediatric and neonatal critical care settings; however, its impact on healthcare professional training and on patient outcomes remains less well understood. WHAT IS NEW: • There is a scarcity of rigorous Level 4 evidence linking SBE to patient outcomes in pediatric and neonatal critical care. • We provide a methodological roadmap advocating for mixed-methods and multicenter designs to bridge this clinical evidence gap.
1 May 2026
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Effect of intranasal breast milk administration on cerebral oxygenation, vital signs, and transition time to full oral feeding in preterm infants: a randomized controlled study
UNLABELLED: This study examined the effects of intranasal breast milk administration on cerebral oxygenation, vital signs, and time to transition to full oral feeding in preterm infants. This assessor-blinded, randomized controlled trial included 40 preterm infants with gestational ages between 28+0 and 36+6 weeks. Infants in the intervention group received 0.2 mL of fresh breast milk intranasally three times daily for 3 days. The control group continued to receive routine clinical care. During each intervention period, cerebral oxygenation and vital signs were recorded at baseline (T0), 5 (T1), 15 (T2), and 30 (T3) minutes after the intervention. The time required for preterm infants to achieve full oral feeding was monitored until discharge. Cerebral oxygenation levels of preterm infants who received intranasal breast milk were significantly higher than the control group and respiratory rate was lower at some measurement times. No significant differences were found between groups in oxygen saturation, heart rate, time to full oral feeding, length of hospital stay, vomiting frequency and defecation frequency. CONCLUSION: Intranasal breast milk administration has the potential to increase cerebral oxygenation in preterm infants. The maintenance of oxygen saturation and heart rate, along with good tolerance of the procedure, suggests that this intervention may be safe and feasible. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov on 21 May 2024 (Identifier: NCT06706115). WHAT IS KNOWN: • Intranasal breast milk administration has been reported to have therapeutic potential in improving brain injury in preterm infants. • Intranasal administration of breast milk is known not to cause significant side effects in preterm infants diagnosed with intraventricular hemorrhage. WHAT IS NEW: • Intranasal breast milk administration may increase cerebral rSO₂ in preterm infants. • Intranasal breast milk administration did not affect preterm infants' heart rate, SpO₂ levels, time to transition to full oral feeding, length of hospital stay, daily vomiting, and stooling frequency.
17 Apr 2026
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