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.

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.

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.

Adverse Events and Unsuccessful Intubation Attempts Are Frequent During Neonatal Nasotracheal Intubations.

Background: Intubation of neonates is difficult and hazardous. Factors associated with procedure-related adverse events and unsuccessful intubation attempts are insufficiently evaluated, especially during neonatal nasotracheal intubations. Objective: Aim of this study was to determine the frequency of tracheal intubation-associated events (TIAEs) during neonatal nasotracheal intubations and to identify factors associated with TIAEs and unsuccessful intubation attempts in our neonatal unit. Methods: This was a prospective, single-site, observational study from May 2017 to November 2019, performed at a tertiary care neonatal intensive care unit in a German academic teaching hospital. All endotracheal intubation encounters performed by the neonatal team were recorded. Results: Two hundred and fifty-eight consecutive intubation encounters in 197 patients were analyzed. One hundred and forty-eight (57.4%) intubation encounters were associated with at least one TIAE. Intubation inexperience (<10 intubation encounters) (OR = 2.15; 95% CI, 1.257-3.685) and equipment problems (OR = 3.43; 95% CI, 1.12-10.52) were predictive of TIAEs. Intubation at first attempt (OR = 0.10; 95% CI, 0.06-0.19) and videolaryngoscopy (OR = 0.47; 96% CI, 0.25-0.860) were predictive of intubation encounters without TIAEs. The first intubation attempt was commonly done by pediatric residents (67.8%). A median of two attempts were performed until successful intubation. Restricted laryngoscopic view (OR = 3.07; 95% CI, 2.08-4.53; Cormack-Lehane grade 2 vs. grade 1), intubation by pediatric residents when compared to neonatologists (OR = 1.74; 95% CI, 1.265-2.41) and support by less experienced neonatal nurses (OR = 1.60; 95% CI, 1.04-2.46) were associated with unsuccessful intubation attempts. Conclusions: In our unit, TIAEs and unsuccessful intubation attempts occurred frequently during neonatal nasotracheal intubations. To improve success rates, quality improvement und further research should target interprofessional education and training, equipment problems and videolaryngoscopy.

Low Frequency of Viral Respiratory Tract Infections During Family-Centered Neonatal Intensive Care: Results of a Prospective Surveillance Study.

Background: Viral respiratory tract infections (VRTI) may cause severe respiratory and sepsis-like symptoms in infants hospitalized in the neonatal intensive care unit (NICU). Little is known about the frequencies of VRTI in relation to visiting policies in the NICU. Objective: Aim of this study was to evaluate the frequency of symptomatic and asymptomatic VRTI in our family-centered NICU. Methods: This was a 12-month, prospective, observational study from February 2018 to January 2019. Infants hospitalized ≥72 h were eligible for the study. To determine the frequency of VRTI, multiplexed point-of-care testing (mPOCT) of symptomatic infants was combined with a weekly screening of all infants. Our 10-bed NICU is 24/7 open to families and visitors. The number of simultaneous visitors is restricted to two per patient. Parents and visitors are instructed in hand hygiene and advised to avoid visits in cases of respiratory illness. Siblings irrespective of age may visit the NICU following a physical check-up. Results Multiplexed point-of-care testing (71 symptomatic episodes) combined with the weekly screening (272 episodes) yielded in 21 positive samples from 2 of the 67 infants enrolled in the study. Both infants were first detected during symptomatic episodes. Rhino-/enterovirus were detected in all cases. Conclusion: Respiratory viruses were detected during symptomatic and asymptomatic episodes but affected <3% of infants enrolled in the study. In our unit, a low frequency of VRTI was attained despite adherence to family integrated care including liberal visiting policies for younger siblings.

Unique clockwork in photoreceptor of rat.

In mammals, the retina contains a clock system that oscillates independently of the master clock in the suprachiasmatic nucleus and allows the retina to anticipate and to adapt to the sustained daily changes in ambient illumination. Using a combination of laser capture micro-dissection and quantitative PCR in the present study, the clockwork of mammalian photoreceptors has been recorded. The transcript amounts of the core clock genes Clock, Bmal1, Period1 (Per1), Per3, Cryptochrome2, and Casein kinase Iε in photoreceptors of rat retina have been found to undergo daily changes. Clock and Bmal1 peak with Per1 and Per3 around dark onset, whereas Casein kinase Iε and Cryptochrome2 peak at night. As shown for Clock, Per1, and Casein kinase Iε, the oscillation of transcript amounts results in daily changes of the protein products. The in-phase oscillation of Clock/Bmal1 with Pers and the rhythmic expression of Casein kinase Iε do not occur in molecular clocks of other tissues including the suprachiasmatic nucleus. Therefore, the findings presented suggest that the photoreceptor clock is unique not only in its position outside the clock hierarchy mastered by the suprachiasmatic nucleus, but also with regard to the intrinsic rhythmic properties of its molecular components.