Eligible neonatal donors after circulatory determination of death (Maastricht type III): A national survey of level III NICUs.

BACKGROUND: Organ donation continues to increase worldwide, but in general paediatric patients remain less likely to receive a transplant. The inclusion of neonates as donors after cDCD should be considered in an effort to increase donation rates. METHODS: The survey for a cross-sectional national study of potential cDCD neonatal donors (Maastricht type III) was sent to all 90 level III Spanish neonatal units to explore: 1) protocols, education, and specific opinions on donation and 2) potential cDCD that could have been eligible over a 2-year period (2014-2015). RESULTS: Forty-five centers (50%) completed the survey, and 38/45 gave information about potential eligible donors. In 16% of the centers specific protocols on neonatal donation exist. All hospitals demanded more specific training, and 65% noted that the donation process could be a problem in the family's dismissal of the child. During the study period 46 805 neonates were admitted in the 38 centers, and 625 neonates died. Ninety-five born at a gestational age ≥34 weeks and above 2000 gr died after an EoL decision, 38 (40%) and 13 (14%) of them due to neonatal encephalopathy and multiple congenital anomalies, respectively. There were 31 (33%) elegible infants who died in less than 120 min due to pathologies that did not contraindicate donation. CONCLUSIONS: Neonatal cDCD could help to reduce the gap between the supply of and demand for organs according to the potentially eligible patients emerging from this study. Training in EoL and donation processes should be provided to healthcare professionals.

Lack of changes in preterm delivery and stillbirths during COVID-19 lockdown in a European region.

Preliminary data in Europe have suggested a reduction in prematurity rates during the COVID-19 pandemic, implying that contingency measures could have an impact on prematurity rates. We designed a population-based prevalence proportion study to explore the potential link between national lockdown measures and a change in preterm births and stillbirths. Adjusted multivariate analyses did not show any decrease in preterm proportions during the lockdown period with respect to the whole prelockdown period or to the prelockdown comparison periods (2015-2019): 6.5% (95%CI 5.6-7.4), 6.6% (95%CI 6.5-6.8), and 6.2% (95%CI 5.7-6.7), respectively. Proportions of preterm live births did not change during lockdown when different gestational age categories were analyzed, nor when birthweight categories were considered. No differences in stillbirth rates among the different study periods were found: 0.33% (95%CI 0.04-0.61) during the lockdown period vs. 0.34% (95%CI 0.22-0.46) during the prelockdown comparison period (2015-2019).Conclusion: We did not find any link between prematurity and lockdown, nor between stillbirths and lockdown. Collaborative efforts are desirable to gather more data and additional evidence on this global health issue. What is Known: • Prematurity is associated with increased risk of morbidity and mortality. • Contingency measures during the COVID-19 pandemic may have an impact on reducing prematurity rates. What is New: • Prematurity and stillbirth rates remained stable in Castilla-y-León, a Spanish region, during COVID-19 lockdown. • The role of behavioral patterns and sociocultural factors in the prevention of preterm birth as a result of lockdown measures remains a subject for debate.

[Indicadores de salud perinatal en una región española entre los años 2015 y 2020.] / Perinatal health indicators in a region of Spain corresponding to the period 2015 to 2020.

OBJECTIVE: The availability in the literature of data related to perinatal variables in the Spanish population is very scarce. The aim of this study was to know the evolution of perinatal health indicators according to the risk groups of prematurity and birth weight, the proportion of multiple births, caesarean section and stillbirths. METHODS: We conducted a population-based cross-sectional study of births in eleven hospitals in Castilla y León (January 2015 to June 2020). There were 70,024 newborns from 68,769 deliveries. Jointpoint regression analysis was used to identify changes in trend over the years, and binomial logistic regression was used to adjust for the potential interaction of hospital type, sex, type of delivery and multiple births on the frequencies of prematurity and death. RESULTS: There was a 19.9% decrease in deliveries and a 42% decrease in multiple births, with no change in preterm (7.7%) and stillbirths (0.44%). The percentage of caesarean sections was 21.5% with a slight downward trend over time. Death (stillbirth) was associated with preterm multiple birth; especially with the male-male combination (p<0.05). Late preterm and early term newborns showed higher risk of death compared to term newborns: OR 7.7 (95%CI 5.6-10.7) and 2.4 (95%CI 1.6-3.6), respectively; as well as the low birth weight group (OR 17.6; 95%CI 13.9-22.2) and small for gestational age (OR 3.4; 95%CI 1.9-5.8), compared to those of adequate weight. CONCLUSIONS: Prior to the development of the COVID-19 pandemic there is a decline in births, including multiple births, with no change in stillbirths or prematurity. Late preterm and early term newborns are at increased risk of intrauterine death.

OBJETIVO: La disponibilidad en la literatura de datos relacionados con variables perinatales en la población española son muy escasos. El objetivo de este estudio fue conocer la evolución de los indicadores de salud perinatal atendiendo a los grupos de riesgo de prematuridad y de peso al nacimiento, la proporción de parto múltiple, de cesárea y de mortinatos. METODOS: Se realizó un estudio transversal poblacional de los partos en once hospitales de Castilla y León (enero de 2015 a junio de 2020). Hubo 70.024 recién nacidos (RN) procedentes de 68.769 partos. Se utilizó el análisis de regresión Jointpoint para identificar cambios en la tendencia a lo largo de los años, y la regresión logística binomial para ajustar la potencial interacción del tipo de hospital, el sexo, el tipo de parto y el parto múltiple en las frecuencias de prematuridad y de fallecimiento. RESULTADOS: Hubo un descenso de partos del 19,9% y de los múltiples del 42%, sin cambios en los RN prematuros (7,7%) ni en los mortinatos (0,44%). El porcentaje de cesáreas fue del 21,5% con una ligera tendencia temporal descendente. El fallecimiento (mortinato) se asoció al parto múltiple pretérmino; especialmente a la combinación varón-varón (p<0,05). Los RN pretérminos tardíos y términos precoces mostraron mayor riesgo de fallecer frente a los RN a término: OR 7,7 (IC95% 5,6-10,7) y 2,4 (IC95% 1,6-3,6), respectivamente; así como el grupo de bajo peso (OR 17,6; IC95% 13,9-22,2) y el pequeño para la edad gestacional (OR 3,4; IC95% 1,9-5,8), frente a los de peso adecuado. CONCLUSIONES: Previo al desarrollo de la pandemia por COVID-19 existe un descenso de la natalidad, incluidos los partos múltiples, sin cambios en los mortinatos ni en la prematuridad. Los RN pretérminos tardío y términos precoces tienen mayor riesgo de fallecer intraútero.

Adherence to hypothermia guidelines in newborns with hypoxic-ischemic encephalopathy.

INTRODUCTION: We do not have population data in Spain on the application of therapeutic hypothermia (TH). The objective was to examine adherence to management standards during TH of infants with hypoxic-ischemic encephalopathy (HIE). METHOD: Multicenter observational cohort study from the beginning of TH (year 2010) in 5 hospitals in a Spanish region, until year 2019. RESULTS: 133 patients were recruited, 72% diagnosed with moderate HIE and the rest of them with severe HIE. In 84% of infants, passive hypothermia was started at birth. Active TH was started at a median age of 5 h of life (IQR 3.3; 6.3), although the central targeted temperature (33-34 °C) was reached at a median age of 3.5 h (IQR 1; 6). Those born extramural, initiated active TH 3.3 h on average later than those born intramural, but without differences in the age at which the targeted temperature was reached. Sedoanalgesia was used in 97%. 100% were monitored with amplitude-integrated EEG and 59% with cerebral oxymetry. MRI was performed in 94% with moderate HIE vs. 65% with severe; P < .001. Neuron-specific enolase in cerebrospinal fluid was determined in 42%. The average duration of rewarming was median 10 h (IQR 8; 12), with no differences depending on the degree of HIE (P = .57). CONCLUSIONS: The implementation of TH successfully met the standards. However, aspects of care that could be improved were detected. Auditing newborn care with HIE is crucial to achieving programs with a high quality of care in each region.

[Adherence to hypothermia guidelines in newborns with hypoxic-ischemic encephalopathy]. / Adherencia a los estándares en el tratamiento con hipotermia del recién nacido con encefalopatía hipóxico-isquémica.

INTRODUCTION: We do not have population data in Spain on the application of therapeutic hypothermia (TH). The objective was to examine adherence to management standards during TH of infants with hypoxic-ischemic encephalopathy (HIE). METHOD: Multicenter observational cohort study from the beginning of TH (year 2010) in 5 hospitals in a Spanish region, until year 2019. RESULTS: 133 patients were recruited, 72% diagnosed with moderate HIE and the rest of them with severe HIE. In 84% of infants, passive hypothermia was started at birth. Active TH was started at a median age of 5hours of life (IQR: 3.3-6.3), although the central targeted temperature (33-34°C) was reached at a median age of 3.5hours (IQR: 1-6). Those born extramural, initiated active TH 3.3hours on average later than those born intramural, but without differences in the age at which the targeted temperature was reached. Sedoanalgesia was used in 97%. The 100% were monitored with amplitude-integrated EEG and 59% with cerebral oxymetry. MRI was performed in 94% with moderate HIE vs. 65% with severe; P<.001. Neuron-specific enolase in cerebrospinal fluid was determined in 42%. The average duration of rewarming was median 10hours (IQR: 8-12), with no differences depending on the degree of HIE (P=.57). CONCLUSIONS: The implementation of TH successfully met the standards. However, aspects of care that could be improved were detected. Auditing newborn care with HIE is crucial to achieving programs with a high quality of care in each region.

Temporal Trends in the Severity and Mortality of Neonatal Hypoxic-Ischemic Encephalopathy in the Era of Hypothermia.

INTRODUCTION: There is a paucity of studies examining temporal trends in the incidence and mortality of moderate-to-severe hypoxic-ischemic encephalopathy (HIE) during the last decade of therapeutic hypothermia (TH). METHODS: Multicenter cross-sectional study of all infants ≥35 weeks gestational age diagnosed with moderate-to-severe HIE within 6 h of birth in an extensive region of Spain between 2011 and 2019, in order to detect trend changes over time in the (1) annual incidence, (2) severity of neurological and systemic organ involvement, and (3) neonatal death from HIE. RESULTS: Annual incidence rate of moderate-to-severe HIE was 0.84 (95% confidence interval [CI] 0.7-0.97) per 1,000 births, without trend changes over time (p = 0.8), although the proportion of severe HIE infants showed an average annual decline of 0.86 points (95% CI 0.75-0.98). There were 102 (70%) infants diagnosed with moderate HIE and 44 (30%) with severe HIE. TH was offered to 139/146 (95%) infants. Infants with clinical and/or electrical seizures showed a decreasing trend from 56 to 28% (p = 0.006). Mortality showed a nonstatistically significant decline (p = 0.4), and the severity of systemic damage showed no changes (p = 0.3). Obstetric characteristics remained unchanged, while higher perinatal pH values (p = 0.03) and Apgar scores (p = 0.05), and less need for resuscitation (p = 0.07), were found over time. CONCLUSION: The annual incidence of moderate-to-severe HIE has stabilized at around 1 per 1,000 births, with a temporal trend toward a decrease in severe HIE infants and a slight decline of mortality. No association was found between temporal trends and changes in perinatal/obstetric characteristics over time.

[Incidence of hypoxic-ischaemic encephalopathy and use of therapeutic hypothermia in Spain]. / Incidencia de la encefalopatía hipóxico-isquémica e implementación de la hipotermia terapéutica por regiones en España.

INTRODUCTION: There are no data on the incidence of hypoxic-ischaemic encephalopathy (HIE) and the implementation of therapeutic hypothermia (TH) in Spain. METHODS: This is a cross-sectional, national study, performed using an on-line questionnaire targeting level III neonatal care units in Spain. Participants were requested to provide data of all newborns ≥ 35 weeks of gestational age diagnosed with moderate-severe HIE over a two year-period (2012-2013), and of the implementation of TH up to June 2015. RESULTS: All (90) contacted hospitals participated. HIE incidence rate was 0.77/1000 live newborns (95% CI 0.72 - 0.83). During 2012-2013, 86% of the newborns diagnosed with moderate-severe HIE received TH (active or passive). Active TH was increasingly used, from 78% in 2012 to 85% in 2013 (P=.01). Of the 14% that did not receive TH, it was mainly due to a delay in the diagnosis or inter-hospital transfer, and to the fact that the treatment was not offered. More than half (57%) were born in hospitals where TH was not provided, and passive hypothermia was used for inter-hospital patient transfer, and in 39% of the cases by inappropriately trained personnel. By June 2015, 57 out of 90 centres had implemented TH, of which 54 performed whole-body TH (using servo-controlled devices). The geographical distribution of centres with active TH, and the number of newborn that received TH, was heterogeneous. CONCLUSIONS: The incidence of moderate-severe HIE is homogeneous across Spanish territory. Significant progress is being made in the implementation of TH, however it is necessary to increase the availability of active TH between Autonomous Communities, to improve early diagnosis, and to guarantee high quality patient transfer to referral centres.

Population-Based Study of the National Implementation of Therapeutic Hypothermia in Infants with Hypoxic-Ischemic Encephalopathy.

Data on the incidence of hypoxic-ischemic encephalopathy (HIE) in the first 6 hours of life together with the implementation of therapeutic hypothermia (TH) are relevant to delineate actions to achieve the lowest rates of neonatal mortality, morbidity, and long-term impact on health associated with HIE. This is population-based national survey study, including newborns ≥35 weeks of gestation with moderate-to-severe HIE from all level III neonatal care units, to provide the incidence of HIE for the period 2012-2013, and the implementation of TH up to June 2015 in Spain. Incidence rate was 0.77 per 1000 live births (95% confidence interval 0.72-0.83). By June 2015, 63% (57/90) of the units had implemented TH; 95% of them performed servo-controlled whole-body TH. For the 2-year period, 86% of the newborns diagnosed with moderate-to-severe HIE received TH. Active TH increased in use from 78% in 2012 to 85% in 2013 (p = 0.01). The main reasons for not cooling were a delay in the diagnosis (31/682) and the fact that the treatment was not offered (20/682). Interhospital patient transfer was performed using passive hypothermia, by appropriately trained personnel in 61% of centers. Eighteen percent of newborns with moderate or severe HIE died, without significant differences between the 2 years. Up-to-date knowledge of the national coverage of neonatal care of infants with HIE in developed countries is a prerequisite to reducing the load of HIE in this area and to facilitating coordinated, eliminate investigation.

[Bioethics in end-of-life decisions in neonatology: Unresolved issues]. / La bioética en el final de la vida en neonatología: cuestiones no resueltas.

This document is the result of previous work carried out by different expert groups and submitted to multidisciplinary debate at a Conference about controversial, deficient, or new aspects in the field of neonatal palliative care, such as: 1) the deliberative decision-making process, 2) hospital and domiciliary palliative care, 3) donation after controlled cardiac death, and 4) moral stress in professionals. The most relevant conclusions were: the need to instruct professionals in bioethics and in the deliberative method to facilitate thorough and reasonable decision-making; the lack of development in the field of perinatal palliative care and domiciliary palliative care in hospitals that attend newborns; the need to provide neonatal units with resources that help train professionals in communication skills and in the management of moral distress, as well as delineate operational procedure and guidelines for neonatal organ donation.