Patterns of Safety Incidents in a Neonatal Intensive Care Unit

Introduction: Safety incidents preceding manifest adverse events are barely evaluated in neonatal intensive care units (NICUs). This study aimed at identifying frequency and patterns of safety incidents in our NICU.Methods: A 6-month prospective clinical study was performed from May to October 2019 in a German 10-bed level III NICU. A voluntary, anonymous reporting system was introduced, and all neonatal team members were invited to complete paper-based questionnaires following each particular safety incident. Safety incidents were defined as safety-related events that were considered by the reporting team member as a “threat to the patient's well-being” which “should ideally not occur again.”Results: In total, 198 safety incidents were analyzed. With 179 patients admitted, the incident/admission ratio was 1.11. Medication errors (n = 94, 47%) and equipment problems (n = 54, 27%) were most commonly reported. Diagnostic errors (n = 19, 10%), communication problems (n = 12, 6%), errors in documentation (n = 9, 5%) and hygiene problems (n = 10, 5%) were less frequent. Most safety incidents were noticed after 4–12 (n = 52, 26%) and 12–24 h (n = 47, 24%), respectively. Actual harm to the patient was reported in 17 cases (9%) but no life-threatening or serious events occurred. Of all safety incidents, 184 (93%) were considered to have been preventable or likely preventable. Suggestions for improvement were made in 132 cases (67%). Most often, implementation of computer-assisted tools and processes were proposed.Conclusion: This study confirms the occurrence of various safety incidents in the NICU. To improve quality of care, a graduated approach tailored to the specific problems appears to be prudent

Parental perceptions of informed consent in a study of tracheal intubations in neonatal intensive care.

BACKGROUND AND OBJECTIVE Obtaining informed consent in neonatal emergency research is challenging. The aim of this study was to assess parental perceptions of informed consent following participation in a clinical trial in neonatal emergency care. METHODS This was a supplementary analysis of a randomised controlled trial comparing video and direct laryngoscopy for neonatal endotracheal intubation in the delivery room and neonatal intensive care unit. After obtaining informed consent for the clinical trial, parents were asked to answer a series of self-administered questions about their perceptions of clinical trial participation and the consent process. Informed consent had been given either before birth, after birth but before inclusion in the trial, or after inclusion in the trial. RESULTS We received responses from 33 mothers and 27 fathers (n = 60) of the 63 preterm and term infants who participated in the study. Fifty-three (89.8%, n = 59) parents agreed that infants should participate in clinical trials, and 51 (85%, n = 60) parents agreed that parents should be asked for informed consent. Fifty-three (89.8%, n = 59) parents felt that their infant's participation in this particular trial would be beneficial. Fifty-two (86.7%, n = 60) parents felt that the informed consent process was satisfactory. One parent (100%, n = 1) approached before birth, 23 parents (82.1%, n = 28) approached after birth but before enrolment and 26 (83.9%, n = 31) parents approached after enrolment were satisfied with the timing of the consent process. Eight (13.3%, n = 60) parents felt some pressure to provide informed consent. Of these, two (25%) were approached before enrolment and six (75%) were approached after enrolment. CONCLUSION Parents valued their infant's participation in an emergency neonatal clinical trial and considered it important to be asked for consent. In this study, it seemed less important whether consent was obtained before or after the intervention. Future studies may need to investigate which form of consent is most acceptable to parents for the individual study in question

Characteristics of neonatal herpes simplex virus infections in Germany: results of a 2-year prospective nationwide surveillance study.

OBJECTIVE To assess incidence and burden of neonatal herpes simplex virus (HSV) infections and to explore possible transmission routes. METHODS A 2-year prospective nationwide surveillance study performed in 2017 and 2018. All German paediatric departments (n=464 in 2017, n=441 in 2018) were contacted on a monthly basis to report potential cases of neonatal HSV infections. Infants with a postnatal age of ≤60 days and a positive HSV PCR or HSV culture from skin, mucous membrane, vesicles or conjunctival smear, blood or cerebrospinal fluid were included in the study. RESULTS 37 cases were analysed. 29 patients who exhibited no or only mild clinical symptoms were discharged home without organ damage or neurological abnormalities. Four patients showed significant neurological impairment, one patient required liver transplantation and two patients died during in-patient treatment. The 2-year incidence of neonatal HSV infections was 2.35 per 100 000 live births (95% CI 1.69 to 3.02) and disease-specific mortality was 0.13 per 100 000 live births (95% CI 0.04 to 0.21). Data on possible transmission routes were available in 23 cases. In 20 cases, an orofacial HSV infection was present in one or more family members. An active maternal genital HSV infection was reported in 3 cases. CONCLUSION Neonatal HSV infections are rare in Germany. Most infants have a benign clinical course, but some infants are severely affected. Postnatal HSV exposure may account for a considerable number of neonatal HSV infections

Attitudes and values towards decisions at the margin of viability among expectant mothers at risk for preterm birth.

AIM To explore how expectant mothers at risk for preterm birth would like to be involved in decision-making at the margin of viability and what they would base their decisions on. METHODS This cross-sectional observational study included a mixed-methods post-hoc analysis alongside a previously reported randomised clinical trial. Expectant mothers between 280/7 and 366/7 weeks' gestation who were hospitalised for risk of preterm birth responded to written case vignettes of an impending preterm birth at the margin of viability. Participants responded to closed and open-ended questions that were theoretically coded for attitudes and values towards shared decision-making. RESULTS Sixty-four expectant mothers were included in the analysis, 36 provided written perspectives. Decision-making was perceived as an enormous burden and a potential source of guilt and regret. Weighing personal values in terms of 'fighting for the baby' and 'quality of life' were used to inform the decision-making process. Explicitly stating that any decision is a good decision, empowerment through co-constructing shared decisions rather than simply presenting choices, sharing the clinicians' personal views, and honest, and empathetic counselling were perceived as supportive. CONCLUSION Mothers at risk for preterm birth provided specific insights into their decision-making patterns that may be helpful to clinicians

Video versus direct laryngoscopy to improve the success rate of nasotracheal intubations in the neonatal intensive care setting: a randomised controlled trial

Objective To assess whether video laryngoscopy (VL) for tracheal intubation of neonates results in a higher first-attempt success rate and fewer adverse tracheal intubation-associated events (TIAEs) when compared with direct laryngoscopy (DL).Design Single-centre, parallel group, randomised controlled trial.Setting University Medical Centre Mainz, Germany.Patients Neonates <440/7 weeks postmenstrual age in whom tracheal intubation was indicated either in the delivery room or in the neonatal intensive care unit.Intervention Intubation encounters were randomly assigned to either VL or DL at first attempt.Primary outcome First-attempt success rate during tracheal intubation.Results Of 121 intubation encounters assessed for eligibility, 32 (26.4%) were either not randomised (acute emergencies (n=9), clinicians’ preference for either VL (n=8) or DL (n=2)) or excluded from the analysis (declined parental consent (n=13)). Eighty-nine intubation encounters (41 in the VL and 48 in the DL group) in 63 patients were analysed. First-attempt success rate was 48.8% (20/41) in the VL group compared with 43.8% (21/48) in the DL group (OR 1.22, 95% CI 0.51 to 2.88).The frequency of adverse TIAEs was 43.9% (18/41) and 47.9% (23/48) in the VL and DL group, respectively (OR 0.85, 95% CI 0.37 to 1.97). Oesophageal intubation with concomitant desaturation never occurred in the VL group but in 18.8% (9/48) of intubation encounters in the DL group.Conclusion This study provides effect sizes for first-attempt success rates and frequency of TIAEs with VL compared with DL in the neonatal emergency setting. This study was underpowered to detect small but clinically important differences between the two techniques. The results of this study may be useful in planning future trials

Table2_Parental perceptions of informed consent in a study of tracheal intubations in neonatal intensive care.docx

Background and objectiveObtaining informed consent in neonatal emergency research is challenging. The aim of this study was to assess parental perceptions of informed consent following participation in a clinical trial in neonatal emergency care.MethodsThis was a supplementary analysis of a randomised controlled trial comparing video and direct laryngoscopy for neonatal endotracheal intubation in the delivery room and neonatal intensive care unit. After obtaining informed consent for the clinical trial, parents were asked to answer a series of self-administered questions about their perceptions of clinical trial participation and the consent process. Informed consent had been given either before birth, after birth but before inclusion in the trial, or after inclusion in the trial.ResultsWe received responses from 33 mothers and 27 fathers (n = 60) of the 63 preterm and term infants who participated in the study. Fifty-three (89.8%, n = 59) parents agreed that infants should participate in clinical trials, and 51 (85%, n = 60) parents agreed that parents should be asked for informed consent. Fifty-three (89.8%, n = 59) parents felt that their infant's participation in this particular trial would be beneficial. Fifty-two (86.7%, n = 60) parents felt that the informed consent process was satisfactory. One parent (100%, n = 1) approached before birth, 23 parents (82.1%, n = 28) approached after birth but before enrolment and 26 (83.9%, n = 31) parents approached after enrolment were satisfied with the timing of the consent process. Eight (13.3%, n = 60) parents felt some pressure to provide informed consent. Of these, two (25%) were approached before enrolment and six (75%) were approached after enrolment.ConclusionParents valued their infant's participation in an emergency neonatal clinical trial and considered it important to be asked for consent. In this study, it seemed less important whether consent was obtained before or after the intervention. Future studies may need to investigate which form of consent is most acceptable to parents for the individual study in question.</p

Table3_Parental perceptions of informed consent in a study of tracheal intubations in neonatal intensive care.docx

Background and objectiveObtaining informed consent in neonatal emergency research is challenging. The aim of this study was to assess parental perceptions of informed consent following participation in a clinical trial in neonatal emergency care.MethodsThis was a supplementary analysis of a randomised controlled trial comparing video and direct laryngoscopy for neonatal endotracheal intubation in the delivery room and neonatal intensive care unit. After obtaining informed consent for the clinical trial, parents were asked to answer a series of self-administered questions about their perceptions of clinical trial participation and the consent process. Informed consent had been given either before birth, after birth but before inclusion in the trial, or after inclusion in the trial.ResultsWe received responses from 33 mothers and 27 fathers (n = 60) of the 63 preterm and term infants who participated in the study. Fifty-three (89.8%, n = 59) parents agreed that infants should participate in clinical trials, and 51 (85%, n = 60) parents agreed that parents should be asked for informed consent. Fifty-three (89.8%, n = 59) parents felt that their infant's participation in this particular trial would be beneficial. Fifty-two (86.7%, n = 60) parents felt that the informed consent process was satisfactory. One parent (100%, n = 1) approached before birth, 23 parents (82.1%, n = 28) approached after birth but before enrolment and 26 (83.9%, n = 31) parents approached after enrolment were satisfied with the timing of the consent process. Eight (13.3%, n = 60) parents felt some pressure to provide informed consent. Of these, two (25%) were approached before enrolment and six (75%) were approached after enrolment.ConclusionParents valued their infant's participation in an emergency neonatal clinical trial and considered it important to be asked for consent. In this study, it seemed less important whether consent was obtained before or after the intervention. Future studies may need to investigate which form of consent is most acceptable to parents for the individual study in question.</p