The impact of combined administration of surfactant and intratracheal budesonide compared to surfactant alone on bronchopulmonary dysplasia (BPD) and mortality rate in preterm infants with respiratory distress syndrome: a single-blind randomized clinical trial.

BACKGROUND: Respiratory distress syndrome (RDS) is one of the most important and common disorders among premature infants. OBJECTIVE: This study aimed to compare the effect of the combination of surfactant and budesonide with surfactant alone on Bronchopulmonary dysplasia (BPD) and mortality rate among premature infants with RDS. METHOD: An outcome assessor-blind randomized clinical trial was conducted on 134 premature infants with RDS who were born in Ayatollah Mousavi Hospital, Zanjan, Iran in 2021. The covariate adaptive randomization method was utilized to allocate participants into two groups (surfactant alone and a combination of surfactant and budesonide). The primary outcomes were BPD and Mortality rate from admission to hospital discharge. The data in this study were analyzed using SPSS software version 18. RESULTS: Overall the comparison of mortality rate and BPD between the two groups did not show a significant difference(p > 0.05). The subgroup results showed that administering surfactant with budesonide to infants under 30 weeks of age significantly reduced the number of deaths compared to using surfactant alone (5 vs. 17). Similar positive effects were observed for the occurrence of Pulmonary Hemorrhage, the need for a second dose of surfactant, oxygen index, mean blood pressure and mean arterial pressure (MAP) in infants under 34 weeks of age compared to more than 34 weeks (p < 0.05). CONCLUSION: These findings suggest that the combination therapy of surfactant and budesonide may be beneficial, particularly in preterm infants with less than 34 weeks gestational age and 1500 birth weight. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and assess long-term outcomes. TRIAL REGISTRATION: The study was registered at the Iranian Registry of Clinical Trials website under the code IRCT20201222049802N1. https://en.irct.ir/user/trial/48117/view . REGISTRATION DATE: 28/02/2021. PUBLIC REPOSITORY: DATA SET: This research data set link is displayed on the Zanjan-Iran Medical Sciences website: https://repository.zums.ac.ir/cgi/users/login? target=https%3 A%2 F/repository.zums.ac.ir/id/eprint .

Creation of a rating scale to teach Less Invasive Surfactant Administration (LISA) in simulation.

BACKGROUND: Simulation-based training is gaining increasing prominence in neonatology training. The Less Invasive Surfactant Administration (LISA) method is starting to be taught in simulation. The aim of this educational study was to develop and validate a rating scale for teaching the LISA method in simulation. METHODS: The Downing framework was used to create this performance-rating scale. A first version of the scale was submitted to 12 French and Belgian experts to obtain their opinions. Consensus was reached using a modified Delphi method. The performance of 40 pediatricians was then evaluated with this scale on a preterm neonate manikin simulating a neonatal respiratory distress syndrome. Each run was evaluated using the scale by two independent observers based on video recordings. RESULTS: The Cronbach alpha score of the rating scale was 0.72. The intraclass correlation coefficient (ICC) was 0.91 and the scores between raters were not significantly different. Finally, this rating scale correctly distinguished the experienced from the inexperienced learners (p < 0.01). CONCLUSIONS: This rating scale is one of the first rating scales for the evaluation and teaching of the LISA method in simulation. This tool has ample potential for use in clinical practice to evaluate the performance of surfactant administration in preterm neonates.

A surfactant-based dressing can reduce the appearance of Pseudomonas aeruginosa pigments and uncover the dermal extracellular matrix in an ex vivo porcine skin wound model.

From previous studies, we have shown that viable colony forming units of bacteria and bacterial biofilms are reduced after sequential treatment with a surfactant-based dressing. Here, we sought to test the impact on visible bacterial pigments and the ultrastructural impact following the sequential treatment of the same surfactant-based dressing. Mature Pseudomonas aeruginosa biofilms were grown on ex vivo porcine skin explants, and an imaging-based analysis was used to compare the skin with and without a concentrated surfactant. In explants naturally tinted by bacterial chromophores, wiping alone had no effect, while the use of a surfactant-based dressing reduced coloration. Similarly, daily wiping led to increased immunohistochemical staining for P. aeruginosa antigens, but not in the surfactant group. Confocal immunofluorescent imaging revealed limited bacterial penetration and coating of the dermis and loose pieces of sloughing material. Ultrastructural analysis confirmed that the biofilms were masking the extracellular matrix (ECM), but the surfactant could remove them, re-exposing the ECM. The masking of the ECM may provide another non-inflammatory explanation for delayed healing, as the ECM is no longer accessible for wound cell locomotion. The use of a poloxamer-based surfactant appears to be an effective way to remove bacterial chromophores and the biofilm coating the ECM fibres.

Less Invasive Surfactant Administration (LISA) Versus INSURE Method in Preterm Infants: a Retrospective Study.

Background: Respiratory distress syndrome (RDS) is a major cause of morbidity and mortality in preterm infants. Early nasal CPAP and selective administration of surfactant via the endotracheal tube are widely used in the treatment of RDS in preterm infants. Objective: The aim of this study was to compare the need for intubation and mechanical ventilation after surfactant delivery between LISA-treated and INSURE-treated premature infants with respiratory distress syndrome (RDS). Methods: Retrospective registry-based cohort study enrolled 36 newborns admitted to the neonatal intensive care unit of the "Santa Maria" Hospital of Terni between 2016 and 2023. As a primary outcome, we followed the need for intubation and mechanical ventilation within 72 hours of life, while the secondary outcomes were major neonatal morbidities and death before discharge. Results: The LISA group and the INSURE group included 13 and 23 newborns respectively. Demographic features showed no significant differences between the two groups. The need for mechanical ventilation in the first 72 hours of life was similar in both groups (p >0.99). There were no significant differences in morbidities. Conclusion: LISA and INSURE are equally effective modalities for surfactant administration for the treatment of RDS in preterm infants.

A clinical study evaluating the combination of LISA and SNIPPV for the treatment of respiratory distress syndrome in preterm infants.

To compare the therapeutic effect of less invasive surfactant administration (LISA) followed by synchronized nasal intermittent positive pressure ventilation (SNIPPV) and traditional intubate-Surfactant-Extubate (InSurE) strategy for the treatment of neonatal respiratory distress syndrome (NRDS). A single-center, non-randomized and single- blinded study Tertiary neonatal intensive care unit 89 infants enrolled were preterm with gestational age < 366/7 weeks and clinically diagnosed with neonatal RDS (NRDS) Interventions: 32 infants were assigned to the LISA + SNIPPV group and 57 infants to the InSurE + nCPAP group. No statistically significant differences were noted in the baseline characteristics of the enrolled infants. A lower proportion of infants developed BPD in the LISA + SNIPPV group compared to the InSurE + CPAP group [10 (31.25%) vs. 21 (36.84%), P > 0.05]; however, there was no statistically significant difference. The number needed to treat (NNT) with LISA + SNIPPV to prevent BPD development is 18. The mortality rate was not significant between our study arms [1 (3.13%) vs 2 (3.51%), P > 0.05]. There were no statistically significant differences in the durations (days) of MV [(12.18 ± 13.89) vs. (11.35 ± 11.61), P > 0.05], oxygen therapy [(35.03 ± 19.13) vs. (39.75 ± 17.91), P > 0.05] and re-intubation rates [(0.19 ± 0.40) vs. (0.21 ± 0.45), P > 0.05] between the two study groups. In terms of complications, the incidence of patent ductus arteriosus (PDA) [24 (75.00%) vs. 27 (47.37%), P < 0.05] was higher and a lower rate of disturbed liver function [1 (3.23%) vs. 19 (33.33%), P < 0.05] were observed in the LISA + SNIPPV group. Acid-base imbalances were reportedly significantly higher in the InSurE group (P < 0.05). No significant differences in other complications were noted. In the interventional group, FiO2 requirements were significantly lower up until the 3rd week of treatment [FiO2 at day 0, (30.75 ± 4.78) vs. (34.66 ± 9.83), P < 0.05; FiO2 at day 21, (25.32 ± 3.74) vs. (29.11 ± 8.17), P < 0.05], as was RSS on days 2 [(0.77 ± 0.38) vs. (1.94 ± 0.75), P < 0.05] and 3 [(0.66 ± 0.33) vs. (1.89 ± 0.82), P < 0.05] after treatment. Additionally, infants in the standard group had a significantly prolonged hospital stay (days) [(45.97 ± 16.93) vs. (54.40 ± 16.26), P < 0.05]. The combination of LISA and SNIPPV for NRDS can potentially lower the rate of BPD, FiO2 demand and shorten the length of hospitalization.

Use of surfactant beyond respiratory distress syndrome, what is the evidence?

Surfactant replacement therapy is currently approved by the United States Food and Drug Administration (FDA) for premature infants with respiratory distress syndrome (RDS) caused by surfactant deficiency due to immaturity. There is strong evidence that surfactant decreases mortality and air leak syndromes in premature infants with RDS. However, surfactant is also used "off-label" for respiratory failure beyond classic RDS. This review discusses current evidence for the use of off-label surfactant therapy for (1) term infants with lung disease such as meconium aspiration syndrome (MAS), pneumonia/sepsis, and congenital diaphragmatic hernia (2) premature infants after 72 h for acute respiratory failure, and (3) the use of surfactant lavage. At last, we briefly describe the use of surfactants for drug delivery and the current evidence on evaluating infants for surfactant deficiency.

Nanoemulsion potentiates the anti-cancer activity of Myricetin by effective inhibition of PI3K/AKT/mTOR pathway in triple-negative breast cancer cells.

Triple-negative breast cancer (TNBC) is a heterogeneous tumor with a poor prognosis and high metastatic potential, resulting in poor clinical outcomes, necessitating investigation to devise effective therapeutic strategies. Multiple studies have substantiated the anti-cancer properties of the naturally occurring flavonoid "Myricetin" in various malignancies. However, the therapeutic application of Myricetin is impeded by its poor water solubility and low oral bioavailability. To overcome this limitation, we aimed to develop nanoemulsion of Myricetin (Myr-NE) and evaluate its advantage over Myricetin alone in TNBC cells. The nanoemulsion was formulated using Capryol 90 (oil), Tween 20 (surfactant), and Transcutol HP (co-surfactant). The optimized nano-formulation underwent an evaluation to determine its size, zeta potential, morphology, stability, drug encapsulation efficiency, and in vitro release properties. The anti-cancer activity of Myr-NE was further studied to examine its distinct impact on intracellular drug uptake, cell-viability, anti-tumor signaling, oxidative stress, clonogenicity, and cell death, compared with Myricetin alone in MDA-MB-231 (TNBC) cells. The in vitro drug release and intracellular drug uptake of Myricetin was significantly increased in Myr-NE formulation as compared to Myricetin alone. Moreover, Myr-NE exhibited significant inhibition of cell proliferation, clonogenicity, and increased apoptosis with ~ 2.5-fold lower IC50 as compared to Myricetin. Mechanistic investigation revealed that nanoemulsion augmented the anti-cancer efficacy of Myricetin, most likely by inhibiting the PI3K/AKT/mTOR pathway, eventually leading to enhanced cell death in TNBC cells. The study provides substantial experimental evidence to support the notion that the Myr-NE formulation has the potential to be an effective therapeutic drug for TNBC treatment.

Concentrated surfactant gel dressing for effective wound healing in pediatric patients: a case series.

BACKGROUND: CSG dressing is water-soluble and helps to hydrate the wound, control exudate, and provide gentle debridement by virtue of a high concentration of surfactant micelles. The primary objective of this retrospective case series is to report on the feasibility of CSG use in pediatric wounds and its mechanism of action. The secondary aim was to measure pain during application and removal of CSG. METHODS: Eight pediatric patients ranging in age from newborn to a few months old with wounds requiring medical intervention were treated with CSG. The CSG dressing was applied twice daily at initiation of treatment in some patients, but mostly once daily. NIPS was utilized for pain measurements. RESULTS: Near-complete healing of wounds was observed by the end of treatment duration, which was only a few days. The calm temperament of these patients during dressing changes and objective NIPS suggested minimal to no pain. None of the patients experienced any adverse events related to the use of this dressing. CONCLUSION: The CSG dressing could be the dressing of choice in this population to enhance debridement and maintain moist healing and support granulation, either proactively or if other treatments fail.

Lipopeptide biosurfactant as a potential root canal irrigation agent: Antimicrobial and anti-biofilm evaluation.

OBJECTIVES: Lipopeptide Biosurfactant (LB) is a bacteria derived compound able to reduce surface tension between water and hydrophobic substances and exhibit antimicrobial and anti-biofilm properties. This study aimed to investigate the antimicrobial and anti-biofilm effect of a Lipopeptide Biosurfactant (LB) on Enterococcus faecalis, and its potential use in root canal treatment, either as a standalone irrigation solution or in conjunction with sodium hypochlorite (NaOCl). METHODS: LB was extracted from Bacillus clausii isolate and the dry extract was diluted in deionized water. The antimicrobial effect of LB against planktonic E. faecalis was evaluated by determining the Minimal Inhibitory Concentration (MIC50). The anti-biofilm effect was evaluated by Minimal Biofilm Inhibitory Concentration (MBIC50) and Minimal Biofilm Eradication Concentration (MBEC50) assays on biofilm grown on dentin specimen surface. To evaluate the effectiveness of LB as a single irrigation solution and as a pre-irrigation prior to NaOCl, live and dead bacterial cells were quantified using Confocal Laser Scanning Microscopy (CLSM), and cell biomass was assessed. RESULTS: LB exhibited an MIC50 and MBIC50 of 100 ppm, with an MBEC50 of 1000 ppm, resulting in 52.94 % biofilm inhibition and 60.95 % biofilm eradication on dentin specimens. The effectiveness was concentration-dependent, at 500 ppm, LB demonstrated comparable antimicrobial efficacy to 2.5 % NaOCl. Pre-irrigation with LB resulted in lower biofilm biomass compared to NaOCl alone. CONCLUSION: Pre-irrigation with LB enhanced the antimicrobial effect when followed by NaOCl irrigation. Consequently, LB shows promise as both a standalone root canal irrigation solution and as an adjunct to NaOCl in root canal treatment. CLINICAL SIGNIFICANCE: The study highlights the potential of Lipopeptide Biosurfactant (LB) as an environmentally friendly irrigation solution for root canal treatment, demonstrating potent antimicrobial and anti-biofilm properties against Enterococcus faecalis. LB exhibits concentration-dependent efficacy comparable to 2.5 % NaOCl and can be used as a standalone irrigation solution or in conjunction with NaOCl.

Coffee to Make LISA-a-go.

In August of 1963, Patrick Bouvier Kennedy, the fourth child of Jackie Onassis Kennedy and John F. Kennedy, died less than 48 hours after his birth from respiratory distress syndrome (RDS) of the newborn. His tragic death inspired research into the physiology of RDS, one product of which was the development of surfactant replacement therapies which have saved millions of neonates from a similar fate. Shortly after the demonstration of its efficacy in 1980, exogenous surfactant replacement therapy became the mainstay intervention for RDS.1 Exogenous surfactant was originally administered via an endotracheal tube in mechanically ventilated neonates, a practice which may lead to ventilator-induced injury to the immature lung.

Caffeine and Less Invasive Surfactant Administration for Respiratory Distress Syndrome of the Newborn.

BACKGROUND: Management strategies for preterm neonates with respiratory distress syndrome include early initiation of continuous positive airway pressure (CPAP) and titration of fractional inspired oxygen and may include the use of less invasive surfactant administration (LISA) to avoid the need for endotracheal intubation. This randomized trial investigated whether early administration of caffeine and LISA would decrease the need for endotracheal intubation in the first 72 hours of life (HoL) compared with caffeine and CPAP alone. METHODS: Eligible neonates born at 24 weeks 0 days to 29 weeks 6 days of gestational age were randomly assigned to receive intravenous caffeine in the first 2 HoL followed by surfactant administration via the LISA method (intervention) or caffeine followed by CPAP (control). The primary outcome was the frequency of neonates requiring endotracheal intubation or meeting respiratory failure criteria between groups (caffeine and LISA vs. caffeine and CPAP) within the first 72 HoL. Multivariable logistic regression modeling was used to adjust for gestational age strata in normally distributed primary and secondary outcomes. RESULTS: Enrollment occurred between January 2020 and December 2022. Endotracheal intubation or meeting respiratory failure criteria within the first 72 HoL occurred in 21 (23%) of 92 neonates randomly assigned to receive caffeine and LISA compared with 47 (53%) of 88 neonates in the caffeine and CPAP group (odds ratio, 0.258; 95% confidence interval, 0.136 to 0.490; P<0.001), which remained significant after adjusting for gestational age strata (odds ratio, 0.227; 95% confidence interval, 0.112 to 0.460; P<0.001). Adverse events were similar between groups, except bronchopulmonary dysplasia, which occurred in 26% of the LISA group and 39% of the control group (P=0.049). CONCLUSIONS: In preterm neonates supported with CPAP, early caffeine and LISA resulted in a lower frequency of endotracheal intubation within the first 72 HoL. (Funded by Chiesi USA; ClinicalTrials.gov number, NCT04209946.)

Snappe ii: analysis of accuracy and determination of the cutoff point as a death predictor in a brazilian neonatal intensive care unit / Snappe ii: análise da acurácia e determinação do ponto de corte como preditor de óbito em uma unidade de terapia inensiva neonatal brasileira

ABSTRACT Objective: To analyze the accuracy of the Score for Neonatal Acute Physiology Perinatal Extension (SNAPPE II) as a death predictor, to determine the cutoff point for mortality, and to analyze the association of independent variables with death. Methods: Prospective, longitudinal, hospital-based study on newborns admitted to the Neonatal Intensive Care Unit (NICU) for the first time from November 1, 2016 to April 30, 2017. Newborns with less than 12 hours of length of stay at the NICU, out-of-hospital births, major congenital malformations, and inter-hospital transfer were excluded. Variables were grouped according to hierarchical framework, related to maternal characteristics (distal level), prenatal and childbirth care (intermediate level), and birth conditions (proximal level). Descriptive analyses of SNAPPE II score ranges, Receiver Operating Characteristics Curve (ROC curve) to define the cutoff point for mortality, and bivariate analysis by the Wald test and multiple logistic regression were conducted. Results: After selection, the sample consisted of 247 newborns. In this study, the SNAPPE II cutoff point for mortality was 27, with sensitivity of 84.1% and specificity of 82.4%. 61% of those with a score ≥27 died. Multiple logistic regression showed an association between death and proximal-level variables: sepsis (Odds Ratio [OR] 10.68; 95% confidence interval [95%CI] 2.82-40.48; p<0.001); SNAPPE II ≥27 (OR 5.85; 95%CI 1.90-18.05; p=0.002); birth weight 750-999 g (OR 4.15; 95%CI 1.06-16.14; p=0.040); and nonuse of surfactant (OR 0.159; 95%CI 0.04-0.53; p=0.003). Conclusions: Neonatal mortality was directly proportional to increase in SNAPPE II. Score≥27 increased the odds of dying by six times compared with neonates with lower scores. The proximal variables related to health conditions and neonatal care were associated with death.

RESUMO Objetivo: Analisar a acurácia do Score for Neonatal Acute Physiology Perinatal Extension (SNAPPE II) como preditor de óbito, determinar o ponto de corte para mortalidade e analisar a associação das variáveis independentes com óbito. Métodos: Estudo prospectivo, longitudinal, de base hospitalar com recém-nascidos admitidos pela primeira vez na Unidade de Terapia Intensiva Neonatal (UTIN) entre 1° de novembro de 2016 e 30 de abril de 2017. Foram excluídos recém-nascidos com permanência menor que 12 horas na UTIN, nascimento extra-hospitalar, malformações congênitas maiores e transferência inter-hospitalar. As variáveis foram agrupadas sob determinação hierarquizada, relacionadas a características maternas (nível distal), assistência ao pré-natal e parto (nível intermediário) e condições do nascimento (nível proximal). Foram conduzidas análises descritivas dos graus de pontuação do SNAPPE II, Receiver Operating Characteristics Curve (curva ROC) para definição do ponto de corte para mortalidade e análise bivariada pelo teste de Wald e regressão logística múltipla. Resultados: Após seleção, a amostra constituiu-se de 247 recém-nascidos. Neste estudo, o ponto de corte do SNAPPE II para mortalidade foi 27, com sensibilidade de 84,1% e especificidade de 82,4%. Evoluíram a óbito 61% daqueles com pontuação ≥27. A regressão logística múltipla mostrou associação entre óbito e variáveis de nível proximal: sepse (Odds Ratio [OR] 10,68; intervalo de confiança de 95% [IC95%] 2,82-40,48; p<0,001); pontuação ≥27 (OR 5,85; IC95% 1,90-18,05; p=0,002); peso ao nascer entre 750 e 999 g (OR 4,15; IC95% 1,06-16,14; p=0,040); e não uso de surfactante (OR 0,159; IC95% 0,04-0,53; p=0,003). Conclusões: A mortalidade neonatal foi diretamente proporcional ao aumento do SNAPPE II. Escore≥27 aumentou seis vezes a chance de óbito em relação aos neonatos com escore inferior. As variáveis proximais relacionadas às condições de saúde e da atenção neonatal associaram-se ao óbito.

Estrategia de intervención para disminuir la mortalidad por Síndrome de Dificultad Respiratoria del recién nacido en Maternidad Provincial, de Matanzas / Interventional strategy to diminish mortality by Respiratory Distress Syndrome of the newborn at the Provincial Maternity Hospital, of Matanzas

En la presente investigación se expone una estrategia de intervención dirigida a disminuir la mortalidad por Síndrome de Dificultad Respiratoria del Recién Nacido, en el Hospital Provincial Ginecobstétrico Docente Julio Alfonso Medina, de Matanzas. Sobre la base de la propia experiencia de los autores y mediante la aplicación de métodos científicos, basados en la literatura internacional actual, se presenta el resultado de un minucioso estudio de 48 recién nacidos que padecieron la enfermedad y que fueron tratados en la Unidad de Cuidados Intensivos Neonatales de esa institución hospitalaria durante los años 2006 y 2007. Las acciones estratégicas que se dan a conocer como resultado de la investigación, unido a las recomendaciones ofrecidas por los autores, constituyen una herramienta imprescindible para emprender un mejor manejo con los pacientes que padecen la enfermedad. Apoyados en el uso de una secuencia correcta del CPAP y del surfactante porcino cubano denominado SURFACEN, se dan a conocer nuevos enfoques en el tratamiento del Síndrome de Dificultad Respiratoria del Recién Nacido. Se propone el nuevo término de Enfermedad Pulmonar por Inmadurez Congénita (EPIC), para designar esta patología en lugar del término anatomopatológico de membrana hialina...

In the current investigation we expose the interventional strategy to diminish mortality by Respiratory Difficulty Syndrome of the Newborn, in the Provincial Gynecoobstetric Teaching Hospital Julio Alfonso Medina, of Matanzas. On the basis of the authors' proper experience and applying scientific methods, taking into account the current international literature, we present the results of a detailed study of 48 newborns who suffered the disease and were treated in the Neonatal Intensive Care Unit of this institution during 2006 and 2007. The strategic actions resulting from our investigation, together with the recommendations offered by the authors are indispensable for a better management of the patients suffering the disease. We offer new approaches in the treatment of the Respiratory Distress Syndrome of the Newborn on the basis of the usage of a correct sequence of the Continuous Positive Airway Pressure and the porcine Cuban surfactant called SURFACEN. We propose the new term Pulmonary Disease by Congenital Immaturity, to denominate this pathology in the place of the anatomopathologic term of hyaline membrane...

Evaluación de la efectividad de un programa de cuidado intensivo neonatal. Impacto de la incorporación de surfactante / Effectiveness assessment of a neonatal intensive care program for very low birth weight infants. Impact of surfactant administration

Introducción. La implementación de medidas terapéuticas en la Unidades de Cuidado Intensivo Neonatal (UCIN) se ha estudiado mediante medidas de eficacia (estudios aleatorizados), pero se han realizado pocas evaluaciones sobre su impacto en la práctica diaria, es decir, medición de la efectividad. Objetivo. Determinar si ha variado la efectividad en una UCIN durante un período de 14 años, comparando el efecto del cambio de actitud en la reanimación antes del uso masivo de surfactante y después de él en la calidad de la supervivencia neonatal en un hospital general. Métodos. Se incluyeron todos los pacientes ingresados en UCIN con un peso al nacer (PN) ≤1.500 g,durante un período de 14 años: 1989-1992 (n= 145), 1993-2002 (n= 342). Los sobrevivientes fueron seguidos hasta los 2 años de edad. Las tasas de seguimiento fueron de 80 por ciento y 85 por ciento en los períodos estudiados. Para el estudio se dividieron los pacientes en 4 grupos a intervalos de 250 g, entre 500 y 1.500 g. Medida de resultados. Supervivencia y calidad ajustada de supervivencia. Para estimar la calidad de la supervivencia se empleó el cálculo de los años de vida ganados (AVG). Se crearon categorías para cuantificar la pérdida de AVG por discapacidad. El tiempo de internación se analizó según las categorías de peso y la variación de la mortalidad durante los dos períodos. Resultados. La tasa de supervivencia tuvo un incremento absoluto del 23 por ciento entre los 2 períodos observados 52 por ciento contra 75 por ciento). Se calculó la supervivencia actuarial en los cuatro grupos con un incremento significativo en los 4 grupos (p menos 0,001) más marcado entre 500-749 g (4 por ciento contra 33 por ciento). Los AVG presentaron diferencias significativas en los grupos con PN menor750 g (p menor 0,002, 3,6 contra 23,4) y 750-999 g (p menor 0,001; 22,3 contra 48) no observándose diferencias en los otros dos grupos de PN.

Auto-suficiência e inovação na produção de vacinas e saúde pública / Self-sufficiency and innovation in the production of vaccines and in public health

O Butantan desenvolve novas tecnologias e processos industriais para a produção de imunobiológicos, tendo como prioridade a saúde pública. Produz 150 milhões de doses de antígenos vacinais por ano, 82 por cento da produção nacional e 65 por cento dos soros, fornecidos a preços acessíveis ao Ministério da Saúde para distribuição universal a crianças e idosos. Novos desenvolvimentos incluem a nova vacina contra coqueluche, por um processo que permite simultaneamente produzir um adjuvante que permitirá reduzir a um quarto a dose da vacina sazonal e pandêmica da influenza, aumentando a produção e reduzindo custos; a vacina de raiva humana com o maior rendimento descrito e a vacina combinada BCG-hepatite B-pertussis da maternidade. Em colaboração comNIH, Path e PDVI, o Butantan está iniciando a produção e o ensaio das vacinas para rotavírus e dengue. O surfactante deve reduzir a mortalidade neonatal que as vacinasnão protegem.

Principios de la bioética en la investigación del surfacén en recién nacidos prematuros / Bioethic principles in the investigation of surfacen in premature new born infants

Se hace un análisis desde el punto de vista de los principios de la bioética, sobre la investigación en la fase III de ensayo clínico de la aplicación del surfacén para el síndrome de dificultad respiratoria del recién nacido, la cual se llevó a efecto en Cuba. El colectivo de investigadores tuvo que enfrentar una serie de disyuntivas bioéticas que pusieron de manifiesto la integridad de ese colectivo. Se demuestra que los principios de la bioética: beneficiencia, no mal eficiencia, autonomía y justicia, se tuvieroon en cuenta en el protocolo de la investigación y durante la ejecución de ésta. Según este análisis, se justifica que se tomara un grupo control histórico, en lugar de un grupo control placebo, para las comparaciones de la utilización del surfacén y que se optara por el consentimiento parental después de una información verbal por el médico, sin necesidad de utilizar un documento de consentimiento escrito