Análisis de la evolución de los determinantes pronósticos intrahospitalarios en la población de recién nacidos de muy bajo peso en las últimas décadas

Primera publicación. El objetivo principal fue analizar la evolución de la velocidad de crecimiento del grupo de los recién nacidos de muy bajo peso durante los últimos 24 años en relación con las estrategias nutricionales implantadas en una unidad neonatal de alta complejidad. Se incluyeron 1651 niños. Se objetivó un aumento significativo de la velocidad de crecimiento media entre el primer (1990) y el último año (2013) de 3,27 g/Kg/día (p<0,01) con aumento significativo de la tasa de lactancia materna. Se concluyó que las prácticas nutricionales incorporadas en nuestra unidad durante los últimos 24 años han permitido aumentar de forma global la velocidad de crecimiento en el grupo de los recién nacidos de muy bajo peso, siendo este aumento mayor en el subgrupo de bajo peso para la edad gestacional. Segunda publicación. El objetivo principal fue validar en nuestra población un modelo predictivo de mortalidad o discapacidad severa a los 7 años de edad corregida de los recién nacidos menor de 1250g que tiene en cuenta la combinación de morbilidades mayores del paciente prematuro durante el periodo neonatal (retinopatía del prematuro, displasia broncopulmonar y lesión cerebral grave). Se reclutaron 1001 niños y se objetivó una asociación importante entre la retinopatía del prematuro grave y un pobre desarrollo (OR 3,17, IC 95%: 1,56 – 6,50) y con la displasia broncopulmonar (OR 1,52, IC 95%: 1,03 – 2,2). Además, la combinación de 2 de las 3 comorbilidades neonatales incrementó el riesgo de un pobre desarrollo (OR 4,44, IC 95%: 1,51 – 7,86). Se concluyó que el modelo neonatal basado en las morbilidades mayores de la prematuridad durante el periodo intrahospitalario es válido para predecir mortalidad o discapacidad severa a los 7 años de edad en los recién nacidos con menos de 1250 g de peso al nacimiento. Tercera publicación. El objetivo principal fue determinar si existe una asociación entre la velocidad de crecimiento media intrahospitalaria de los recién nacidos de muy bajo peso al nacimiento y la somatometría a los 2 años de edad corregida. Se incluyeron los recién nacidos del período 1990-2015, con peso al nacer < 1500 g. Se reclutaron 1194 pacientes. La velocidad de crecimiento adecuada se asoció a mayor mediana de peso a los 2 años de edad corregida en la cohorte global (11 400 g [10 300-12 500] versus 11 000 g [10 000-12 140], p = 0,02. Se concluyó que una adecuada VC media intrahospitalaria mejora la somatometría a los 2 años de edad en los recién nacidos de muy bajo peso

Extremely Preterm Infant Admissions Within the SafeBoosC-III Consortium During the COVID-19 Lockdown

Objective: To evaluate if the number of admitted extremely preterm (EP) infants (born before 28 weeks of gestational age) differed in the neonatal intensive care units (NICUs) of the SafeBoosC-III consortium during the global lockdown when compared to the corresponding time period in 2019. Design: This is a retrospective, observational study. Forty-six out of 79 NICUs (58%) from 17 countries participated. Principal investigators were asked to report the following information: (1) Total number of EP infant admissions to their NICU in the 3 months where the lockdown restrictions were most rigorous during the first phase of the COVID-19 pandemic, (2) Similar EP infant admissions in the corresponding 3 months of 2019, (3) the level of local restrictions during the lockdown period, and (4) the local impact of the COVID-19 lockdown on the everyday life of a pregnant woman. Results: The number of EP infant admissions during the first wave of the COVID-19 pandemic was 428 compared to 457 in the corresponding 3 months in 2019 (−6.6%, 95% CI −18.2 to +7.1%, p = 0.33). There were no statistically significant differences within individual geographic regions and no significant association between the level of lockdown restrictions and difference in the number of EP infant admissions. A post-hoc analysis based on data from the 46 NICUs found a decrease of 10.3%in the total number of NICU admissions (n = 7,499 in 2020 vs. n = 8,362 in 2019). Conclusion: This ad hoc study did not confirm previous reports of a major reduction in the number of extremely pretermbirths during the first phase of the COVID-19 pandemic. Clinical Trial Registration: ClinicalTrial.gov, identifier: NCT04527601 (registered August 26, 2020), https://clinicaltrials.gov/ct2/show/NCT04527601

Lateral Kangaroo Care in Hemodynamic Stability of Extremely Preterm Infants: Protocol Study for a Non-Inferiority Randomized Controlled Trial CANGULAT

Introduction: This study aims to assess the efficacy of the modified kangaroo care lateral position on the thermal stability of preterm neonates versus conventional kangaroo care prone position. Material and methods: A non-inferiority randomized parallel clinical trial. Kangaroo care will be performed in a lateral position for the experimental group and in a prone position for the control group preterm. The study will take place at the neonatal intensive care unit (NICU) of a University Hospital. The participants will be extremely premature infants (under 28 weeks of gestational age) along the first five days of life, hemodynamically stable, with mother or father willing to do kangaroo care and give their written consent to participate in the study. The sample size calculated was 35 participants in each group. When the premature infant is hemodynamically stable and one of the parents stays in the NICU, the patient will be randomized into two groups: an experimental group or a control group. The primary outcome is premature infant axillary temperature. Neonatal pain level and intraventricular hemorrhage are secondary outcomes. Discussion: There is no scientific evidence on modified kangaroo care lateral position. Furthermore, there is little evidence of increased intraventricular hemorrhage association with the lateral head position necessary in conventional or prone kangaroo care in extremely premature newborns. Kangaroo care is a priority intervention in neonatal units increasing the time of use more and more, making postural changes necessary to optimize comfort and minimize risks with kangaroo care lateral position as an alternative to conventional prone position kangaroo care. Meanwhile, it is essential to ensure that the conventional kangaroo care prone position, which requires the head to lay sideways, is a safe position in terms of preventing intraventricular hemorrhage in the first five days of life of children under 28 weeks of gestational age. Trial registration at clinicaltrials.gov: NCT03990116.Sin financiación4.614 JCR (2021) Q1, 45/182 Public, Environmental & Occupational Health0.814 SJR (2021) Q1, 34/136 Health, Toxicology and MutagenesisNo data IDR 2021UE

Cerebral Oximetry Monitoring in Extremely Preterm Infants

BACKGROUND The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. METHODS In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, <28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis. RESULTS A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups. CONCLUSIONS In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.)

Additional file 2 of Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

Additional file 2

Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

Abstract Background Data monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Traditional ‘good clinical practice data monitoring’ with on-site monitors increases trial costs and is time consuming for the local investigators. This paper aims to outline our approach of time-effective central data monitoring for the SafeBoosC-III multicentre randomised clinical trial and present the results from the first three central data monitoring meetings. Methods The present approach to central data monitoring was implemented for the SafeBoosC-III trial, a large, pragmatic, multicentre, randomised clinical trial evaluating the benefits and harms of treatment based on cerebral oxygenation monitoring in preterm infants during the first days of life versus monitoring and treatment as usual. We aimed to optimise completeness and quality and to minimise deviations, thereby limiting random and systematic errors. We designed an automated report which was blinded to group allocation, to ease the work of data monitoring. The central data monitoring group first reviewed the data using summary plots only, and thereafter included the results of the multivariate Mahalanobis distance of each centre from the common mean. The decisions of the group were manually added to the reports for dissemination, information, correcting errors, preventing furture errors and documentation. Results The first three central monitoring meetings identified 156 entries of interest, decided upon contacting the local investigators for 146 of these, which resulted in correction of 53 entries. Multiple systematic errors and protocol violations were identified, one of these included 103/818 randomised participants. Accordingly, the electronic participant record form (ePRF) was improved to reduce ambiguity. Discussion We present a methodology for central data monitoring to optimise quality control and quality development. The initial results included identification of random errors in data entries leading to correction of the ePRF, systematic protocol violations, and potential protocol adherence issues. Central data monitoring may optimise concurrent data completeness and may help timely detection of data deviations due to misunderstandings or fabricated data

Additional file 1 of Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

Additional file 1

Cerebral Oximetry Monitoring in Extremely Preterm Infants

Background: The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. Methods: In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, &lt;28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis. Results: A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups. Conclusions: In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.)