Background: Obtaining ethically valid consent to participate in delivery room (DR) studies from parents facing an imminent premature birth can be challenging. This study aims to provide insight... Show moreBackground: Obtaining ethically valid consent to participate in delivery room (DR) studies from parents facing an imminent premature birth can be challenging. This study aims to provide insight into parental experiences with and perceptions of consent for DR studies. Methods: Semistructured interviews were conducted with parents of very and extreme preterm infants. Interviews were audio-recorded, transcribed, and analyzed using the qualitative data analysis software Atlas. ti V.8.4. Results: Twenty-five parents were interviewed. Despite being in an emotional and stressful situation, most parents considered being approached for DR studies as valuable. According to parents, this was mostly due to appropriate timing and communication, compassion, and investigators not being obtrusive. Interviewed parents generally decided to accept or decline study participation based on perceived risk. Parents differed widely in how risk of specific study interventions was perceived, but agreed on the fact that parental consent is needed for DR studies that involve risk. There was no consensus among parents on deferred consent for DR studies running at our NICU. However, parents considered deferred consent appropriate for observational studies. Furthermore, it became clear that parental misunderstanding of various aspects of DR studies, including aims, the concept of randomization, and risk associated with specific interventions, was common. Conclusions: Insight into parental perceptions of consent for DR studies allowed us to determine areas where the validity of parental consent can be improved. Further research on parental perspectives for consent for DR studies will allow us to establish consent procedures that are considered both valid and valuable. Show less
Wagner, M.; Boer, M.C. den; Jansen, S.; Groepel, P.; Visser, R.; Witlox, R.S.G.M.; ... ; Pas, A.B. te 2021
Objective The aim of this study was to determine the experience with, and the feasibility of, point-of-view video recordings using eye-tracking glasses for training and reviewing neonatal... Show moreObjective The aim of this study was to determine the experience with, and the feasibility of, point-of-view video recordings using eye-tracking glasses for training and reviewing neonatal interventions during the COVID-19 pandemic. Design Observational prospective single-centre study. Setting Neonatal intensive care unit at the Leiden University Medical Center. Participants All local neonatal healthcare providers. Intervention There were two groups of participants: proceduralists, who wore eye-tracking glasses during procedures, and observers who later watched the procedures as part of a video-based reflection. Main outcome measures The primary outcome was the feasibility of, and the proceduralists and observers' experience with, the point-of-view eye-tracking videos as an additional tool for bedside teaching and video-based reflection. Results We conducted 12 point-of-view recordings on 10 different patients (median gestational age of 30.9 +/- 3.5 weeks and weight of 1764 g) undergoing neonatal intubation (n=5), minimally invasive surfactant therapy (n=5) and umbilical line insertion (n=2). We conducted nine video-based observations with a total of 88 observers. The use of point-of-view recordings was perceived as feasible. Observers further reported the point-of-view recordings to be an educational benefit for them and a potentially instructional tool during COVID-19. Conclusion We proved the practicability of eye-tracking glasses for point-of-view recordings of neonatal procedures and videos for observation, educational sessions and logistics considerations, especially with the COVID-19 pandemic distancing measures reducing bedside teaching opportunities.Single centre evaluation of the use of eye-tracking glasses during neonatal procedures as an additional tool for outside teaching and video-based reflection. The feasibility and potential benefit during a pandemic is reported. Show less
Boer, M.C. den; Houtlosser, M.; Witlox, R.S.G.M.; Stap, R. van der; Vries, M.C. de; Lopriore, E.; Pas, A.B. te 2021
Background Recording of neonatal resuscitation, including video and respiratory parameters, was implemented for research and quality purposes at the neonatal intensive care unit (NICU) of the... Show moreBackground Recording of neonatal resuscitation, including video and respiratory parameters, was implemented for research and quality purposes at the neonatal intensive care unit (NICU) of the Leiden University Medical Center, and parents were offered to review the recording of their infant together with a neonatal care provider. We aimed to provide insight in parental experiences with reviewing the recording of the neonatal resuscitation of their premature infant. Methods This study combined participant observations during parental review of recordings with retrospective qualitative interviews with parents. Results Parental review of recordings of neonatal resuscitation was observed on 20 occasions, reviewing recordings of 31 children (12 singletons, 8 twins and 1 triplet), of whom 4 died during admission. Median (range) gestational age at birth was 27+5 (24+5-30+3) weeks. Subsequently, 25 parents (13 mothers and 12 fathers) were interviewed. Parents reported many positive experiences, with special emphasis on the value for getting hold of the start of their infant's life and coping with the trauma of neonatal resuscitation. Reviewing recordings of neonatal resuscitation frequently resulted in appreciation for the child, the father and the medical team. Timing and set-up of the review contributed to positive experiences. Parents considered screenshots/copies of the recording of the resuscitation of their infant as valuable keepsakes of their NICU story and reported that having the screenshots/video comforted them, especially when their child died during admission. Conclusion Parents consider reviewing recordings of neonatal resuscitation as valuable. These positive parental experiences could allay concerns about sharing recordings of neonatal resuscitation with parents. Show less
This thesis is about ethics and neonatal resuscitation. More specifically, this thesis discussed ethical challenges that are raised after the decision to provide active care, when neonatal care... Show moreThis thesis is about ethics and neonatal resuscitation. More specifically, this thesis discussed ethical challenges that are raised after the decision to provide active care, when neonatal care providers strive to provide the best possible care. The provision of the best possible care during neonatal resuscitation can be assured throughconducting research and quality improvement activities. However, conducting these activities can be ethically challenging. By combining empirical research with ethicalreasoning, this thesis aimed to provide guidance for the ethical conduct of activities to study and improve neonatal resuscitation. Show less
Background A respiratory function monitor (RFM) provides real-time positive pressure ventilation feedback. Whether providers use RFM during neonatal resuscitation is unknown.Methods Ancillary study... Show moreBackground A respiratory function monitor (RFM) provides real-time positive pressure ventilation feedback. Whether providers use RFM during neonatal resuscitation is unknown.Methods Ancillary study to the MONITOR (NCT03256578) randomised controlled trial. Neonatal resuscitation leaders at two centres wore eye-tracking glasses, and visual attention (VA) patterns were compared between RFM-visible and RFM-masked groups.Results 14 resuscitations (6 RFM-visible, 8 RFM-masked) were analysed. The median total gaze duration on the RFM was significantly higher with a visible RFM (29% vs 1%, p<0.01), while median total gaze duration on other physical objects was significantly lower with a visible RFM (3% vs 8%, p=0.02). Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05).Conclusion Providers' VA patterns differed during neonatal resuscitation when the RFM was visible, emphasising the importance of studying the impact of additional delivery room technology on providers' behaviour. Show less
Boer, M.C. den; Martherus, T.; Houtlosser, M.; Root, L.; Witlox, R.S.G.M.; Pas, A.B. te 2020
Video and physiological parameter recording of neonatal stabilization was implemented at the Neonatal Intensive Care Unit (NICU) of the Leiden University Medical Center. In order to improve... Show moreVideo and physiological parameter recording of neonatal stabilization was implemented at the Neonatal Intensive Care Unit (NICU) of the Leiden University Medical Center. In order to improve documentation and the quality of care provided during neonatal transition, we implemented weekly plenary audits reviewing recordings of neonatal stabilization in 2014. In audits, provided care is reviewed, discussing, among others, mask technique, compliance to the prevailing local guideline, and clinical decision making and alternative treatment options. In this perspective, we argue that auditing neonatal stabilization is a valuable tool to improve patient safety and the quality of care provided during neonatal stabilization. We, therefore, report lessons learned and areas for improvement that could be identified and addressed during audits conducted at our NICU. Important areas for improvement were guideline compliance, documentation, the usage of medical devices, the conduct of delivery room studies, and clinical decision making. By reporting our experiences, we hope to encourage other NICUs to also implement regular audit meetings, fitting to their improvement needs. Show less
Boer, M.C. den; Houtlosser, M.; Foglia, E.E.; Lopriore, E.; Vries, M.C. de; Engberts, D.P.; Pas, A.B. te 2020
Objective To gain insight into neonatal care providers' perceptions of deferred consent for delivery room (DR) studies in actual scenarios.Methods We conducted semistructured interviews with 46... Show moreObjective To gain insight into neonatal care providers' perceptions of deferred consent for delivery room (DR) studies in actual scenarios.Methods We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0.Results Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent.Conclusion Insight into providers' perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on. Show less
Boer, M.C. den; Houtlosser, M.; Foglia, E.E.; Tan, R.N.G.B.; Engberts, D.P.; Pas, A.B. te 2019
Objective To assess benefits of recording and reviewing neonatal resuscitation as experienced by neonatal care providers. Design A qualitative study using semistructured interviews questioning... Show moreObjective To assess benefits of recording and reviewing neonatal resuscitation as experienced by neonatal care providers. Design A qualitative study using semistructured interviews questioning neonatal care providers about their experiences with recording and reviewing neonatal resuscitation. Data were analysed using the qualitative data analysis software Atlas.ti V.7.0. Setting Neonatal care providers working at neonatal intensive care units (NICUs) of the Leiden University Medical Center, the Netherlands, and the University of Pennsylvania School of Medicine, USA, participated in this study. Results In total, 48 NICU staff members were interviewed. Reported experiences and attitudes are broadly similar for both NICUs. All interviewed providers reported positive experiences and benefits, with special emphasis on educational benefits. Recording and reviewing neonatal resuscitation is used for various learning activities, such as plenary review meetings and as tool for objective feedback. Providers reported to learn from reviewing their own performance during resuscitation, as well as from reviewing performances of others. Improved time perception, reflection on guideline compliance and acting less invasively during resuscitations were often mentioned as learning outcomes. All providers would recommend other NICUs to implement recording and reviewing neonatal resuscitation, as it is a powerful tool for learning and improving. However, they emphasised preconditions for successful implementation, such as providing information, not being punitive and focusing on the benefits for learning and improving. Conclusion Recording and reviewing neonatal resuscitation is considered highly beneficial for learning and improving resuscitation skills and is recommended by providers participating in it. Show less
Boer, M.C. den; Houtlosser, M.; Foglia, E.E.; Davis, P.G.; Kaam, A.H. van; Kamlin, C.O.F.; ... ; Pas, A.B. te 2019
