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1.
J Neonatal Perinatal Med ; 17(2): 233-239, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38759030

RESUMO

INTRODUCTION: Respiratory Distress Syndrome (RDS) is the most common respiratory disorder among premature infants. The use of surfactant has significantly reduced respiratory complications and mortality. There are two conventional methods for administering surfactant: Intubate-Surfactant-Extubate (INSURE) and Less Invasive Surfactant Administration (LISA). This study aims to compare the effects of surfactant administration using these two methods on the treatment outcomes of premature newborns. MATERIALS AND METHODS: In this retrospective cohort study, we included 100 premature newborns with RDS and spontaneous breathing who were admitted to the Neonatal Intensive Care Unit of Besat Hospital in Sanandaj city in 2021. Exclusion criteria comprised congenital anomalies and the needing for intubation for resuscitation at birth. The outcomes of epmericaly trated with two methods were compared: the LISA (50 neonates) and the INSURE (50 neonates). Our interesting outcomes were needing for mechanical ventilation, duration of ventilation, pneumothorax, pulmonary hemorrhage, severe retinopathy, CPAP duration, and bronchopulmonary dysplasia. Finally, we entered the data into STATA-14 statistical software and analyzed it using chi-square and t-tests. RESULTS: In this study, 69% of the neonates were boys. The LISA group exhibited significantly lower rates of need for mechanical ventilation (P = 0.003) and ventilation duration (P < 0.001) compared to the INSURE group. Conversely, there were no significant differences between the two groups (P > 0.05) in terms of pneumothorax, pulmonary hemorrhage, severe retinopathy, CPAP duration, and bronchopulmonary dysplasia rates. CONCLUSION: The results of this study suggest that the LISA method is a safe and non-invasive approach for surfactant administration. Notably, it resulted in a reduced need for mechanical ventilation and decreased ventilation duration compared to the INSURE method.


Assuntos
Recém-Nascido Prematuro , Surfactantes Pulmonares , Respiração Artificial , Síndrome do Desconforto Respiratório do Recém-Nascido , Humanos , Surfactantes Pulmonares/administração & dosagem , Surfactantes Pulmonares/uso terapêutico , Recém-Nascido , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Masculino , Estudos Retrospectivos , Feminino , Respiração Artificial/métodos , Intubação Intratraqueal/métodos , Resultado do Tratamento , Unidades de Terapia Intensiva Neonatal , Pressão Positiva Contínua nas Vias Aéreas/métodos , Extubação/métodos , Displasia Broncopulmonar
2.
Zhongguo Dang Dai Er Ke Za Zhi ; 26(4): 337-342, 2024 Apr 15.
Artigo em Chinês | MEDLINE | ID: mdl-38660896

RESUMO

OBJECTIVES: To investigate the effects of different angles of pulmonary surfactant (PS) administration on the incidence of bronchopulmonary dysplasia and intracranial hemorrhage in preterm infants. METHODS: A prospective study was conducted on 146 preterm infants (gestational age <32 weeks) admitted to the Department of Neonatology, Provincial Hospital Affiliated to Anhui Medical University from January 2019 to May 2023. The infants were randomly assigned to different angles for injection of pulmonary surfactant groups: 0° group (34 cases), 30° group (36 cases), 45° group (38 cases), and 60° group (38 cases). Clinical indicators and outcomes were compared among the groups. RESULTS: The oxygenation index was lower in the 60° group compared with the other three groups, with shorter invasive ventilation time and oxygen use time, and a lower incidence of bronchopulmonary dysplasia than the other three groups (P<0.05). The incidence of intracranial hemorrhage was lower in the 60° group compared to the 0° group (P<0.05). The cure rate in the 60° group was higher than that in the 0° group and the 30° group (P<0.05). CONCLUSIONS: The clinical efficacy of injection of pulmonary surfactant at a 60° angle is higher than other angles, reducing the incidence of intracranial hemorrhage and bronchopulmonary dysplasia in preterm infants.


Assuntos
Displasia Broncopulmonar , Recém-Nascido Prematuro , Hemorragias Intracranianas , Surfactantes Pulmonares , Humanos , Surfactantes Pulmonares/administração & dosagem , Recém-Nascido , Estudos Prospectivos , Displasia Broncopulmonar/prevenção & controle , Displasia Broncopulmonar/tratamento farmacológico , Displasia Broncopulmonar/etiologia , Masculino , Feminino , Hemorragias Intracranianas/prevenção & controle , Hemorragias Intracranianas/induzido quimicamente
3.
BMC Pediatr ; 24(1): 272, 2024 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-38664650

RESUMO

INTRODUCTION: Neonatal respiratory failure (NRF) is a serious condition that often has high mortality and morbidity, effective interventions can be delivered in the future by identifying the risk factors associated with morbidity and mortality. However, recent advances in respiratory support have improved neonatal intensive care units (NICUs) care in China. We aimed to provide an updated review of the clinical profile and outcomes of NRF in the Jiangsu province. METHODS: Infants treated for NRF in the NICUs of 28 hospitals between March 2019 and March 2022 were retrospectively reviewed. Data collected included baseline perinatal and neonatal parameters, NICU admission- and treatment-related data, and patient outcomes in terms of mortality, major morbidity, and survival without major morbidities. RESULTS: A total of 5548 infants with NRF were included in the study. The most common primary respiratory disorder was respiratory distress syndrome (78.5%). NRF was managed with non-invasive and invasive respiratory support in 59.8% and 14.5% of patients, respectively. The application rate of surfactant therapy was 38.5%, while that of neonatal extracorporeal membrane oxygenation therapy was 0.2%. Mortality and major morbidity rates of 8.5% and 23.2% were observed, respectively. Congenital anomalies, hypoxic-ischemic encephalopathy, invasive respiratory support only and inhaled nitric oxide therapy were found to be significantly associated with the risk of death. Among surviving infants born at < 32 weeks of gestation or with a birth weight < 1500 g, caffeine therapy and repeat mechanical ventilation were demonstrated to significantly associate with increased major morbidity risk. CONCLUSION: Our study demonstrates the current clinical landscape of infants with NRF treated in the NICU, and, by proxy, highlights the ongoing advancements in the field of perinatal and neonatal intensive care in China.


Assuntos
Unidades de Terapia Intensiva Neonatal , Síndrome do Desconforto Respiratório do Recém-Nascido , Humanos , Recém-Nascido , China/epidemiologia , Estudos Retrospectivos , Feminino , Masculino , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Insuficiência Respiratória/terapia , Surfactantes Pulmonares/uso terapêutico , Surfactantes Pulmonares/administração & dosagem , Oxigenação por Membrana Extracorpórea , Respiração Artificial/estatística & dados numéricos , Resultado do Tratamento
4.
JAMA ; 330(11): 1054-1063, 2023 09 19.
Artigo em Inglês | MEDLINE | ID: mdl-37695601

RESUMO

Importance: The long-term effects of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome remain to be definitively clarified. Objective: To examine the effect of MIST on death or neurodevelopmental disability (NDD) at 2 years' corrected age. Design, Setting, and Participants: Follow-up study of a randomized clinical trial with blinding of clinicians and outcome assessors conducted in 33 tertiary-level neonatal intensive care units in 11 countries. The trial included 486 infants with a gestational age of 25 to 28 weeks supported with continuous positive airway pressure (CPAP). Collection of follow-up data at 2 years' corrected age was completed on December 9, 2022. Interventions: Infants assigned to MIST (n = 242) received exogenous surfactant (200 mg/kg poractant alfa) via a thin catheter; those assigned to the control group (n = 244) received sham treatment. Main Outcomes and Measures: The key secondary outcome of death or moderate to severe NDD was assessed at 2 years' corrected age. Other secondary outcomes included components of this composite outcome, as well as hospitalizations for respiratory illness and parent-reported wheezing or breathing difficulty in the first 2 years. Results: Among the 486 infants randomized, 453 had follow-up data available (median gestation, 27.3 weeks; 228 females [50.3%]); data on the key secondary outcome were available in 434 infants. Death or NDD occurred in 78 infants (36.3%) in the MIST group and 79 (36.1%) in the control group (risk difference, 0% [95% CI, -7.6% to 7.7%]; relative risk [RR], 1.0 [95% CI, 0.81-1.24]); components of this outcome did not differ significantly between groups. Secondary respiratory outcomes favored the MIST group. Hospitalization with respiratory illness occurred in 49 infants (25.1%) in the MIST group vs 78 (38.2%) in the control group (RR, 0.66 [95% CI, 0.54-0.81]) and parent-reported wheezing or breathing difficulty in 73 (40.6%) vs 104 (53.6%), respectively (RR, 0.76 [95% CI, 0.63-0.90]). Conclusions and Relevance: In this follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome supported with CPAP, MIST compared with sham treatment did not reduce the incidence of death or NDD by 2 years of age. However, infants who received MIST had lower rates of adverse respiratory outcomes during their first 2 years of life. Trial Registration: anzctr.org.au Identifier: ACTRN12611000916943.


Assuntos
Surfactantes Pulmonares , Síndrome do Desconforto Respiratório do Recém-Nascido , Feminino , Humanos , Lactente , Recém-Nascido , Dispneia , Seguimentos , Recém-Nascido Prematuro , Lipoproteínas , Surfactantes Pulmonares/administração & dosagem , Surfactantes Pulmonares/uso terapêutico , Síndrome do Desconforto Respiratório/complicações , Síndrome do Desconforto Respiratório/tratamento farmacológico , Síndrome do Desconforto Respiratório/terapia , Síndrome do Desconforto Respiratório do Recém-Nascido/complicações , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Sons Respiratórios , Tensoativos/administração & dosagem , Tensoativos/uso terapêutico , Cateterismo , Procedimentos Cirúrgicos Minimamente Invasivos , Pressão Positiva Contínua nas Vias Aéreas , Masculino , Pré-Escolar
5.
Acta Paediatr ; 111(11): 2108-2114, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35896864

RESUMO

AIM: We explored whether subnormal forced expiratory volume within 1 s (FEV1 ) at 5-9 years of age was lower in children born preterm who received less invasive surfactant administration (LISA) rather than surfactant via an endotracheal tube. METHODS: The multi-centre, randomised Nonintubated Surfactant Application trial enrolled 211 preterm infants born at 23-26 weeks of gestation from 13 level III neonatal intensive care units from April 2009 to March 2012. They received surfactant via LISA (n = 107) or after conventional endotracheal intubation (n = 104). The follow-up assessments were carried out by a single team blinded to the group assignments. The main outcome was FEV1 < 80% of predicted values. RESULTS: Spirometry was successful in 102/121 children. The other children died or were lost to follow-up. Median FEV1 was 93% (interquartile range 80%-113%) of predicted values in the LISA group and 86% (interquartile range 77-102%) in the control group (p = 0.685). Rates of FEV1 < 80% were 11/57 (19%) and 15/45 (33%), respectively, which was an absolute risk reduction of 14% (95% confidence interval -3.1% to 31.2%, p = 0.235). There were no differences in other outcome measures. CONCLUSION: The proportion of children aged 5-9 years with subnormal FEV1 was not significantly different between the groups.


Assuntos
Surfactantes Pulmonares , Criança , Pré-Escolar , Humanos , Recém-Nascido Prematuro , Intubação Intratraqueal , Surfactantes Pulmonares/administração & dosagem , Espirometria
6.
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue ; 34(1): 80-84, 2022 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-35307066

RESUMO

OBJECTIVE: To investigate the efficacy and safety of nasal continuous positive airway pressure (NCPAP) combined with inhalation of pulmonary surfactant (PS) using vibrating mesh nebulizers in the treatment of neonatal respiratory distress syndrome (RDS). METHODS: A prospective study was performed on premature infants with RDS admitted to the First Affiliated Hospital of Bengbu Medical College between December 2020 and June 2021. They were randomly assigned into vibrating mesh atomization technology group and intubation-surfactant-extubation (INSURE) technology group. The two groups were treated with NCPAP combined with PS. PS in the vibrating mesh atomization technology group was inhaled into the lungs by the new vibrating mesh atomization technology, while PS in the INSURE group was injected into the lungs by endotracheal tube. The pH value, arterial partial pressure of carbon dioxide (PaCO2), oxygenation index (PaO2/FiO2), mechanical ventilation via endotracheal tube (MVET) demand rate, duration of respiratory support, secondary use of PS, complications, and hospital mortality were compared between the two groups. The occurrences of adverse events in the two groups were recorded. RESULTS: A total of 42 preterm infants were finally enrolled, including 20 cases in the vibrating mesh atomization technology group and 22 cases in the INSURE technology group. There were no significant differences in blood gas analysis and PaO2/FiO2 before PS administration between the two groups. One hour after PS administration, blood gas analysis and PaO2/FiO2 were significantly improved in both groups. Compared with the INSURE technology group, the improvement of PaO2/FiO2 was more obvious in the vibrating mesh atomization technology group [mmHg (1 mmHg≈0.133 kPa): 198±34 vs. 173±39, P < 0.05], but no significant difference in pH value or PaCO2 was found between the two groups. The duration of respiratory support in the vibrating mesh atomization technology group was significantly shorter than that in the INSURE technology group (hours: 96±13 vs. 120±18, P < 0.01), but there was no statistical difference in MVET demand rate [5.0% (1/20) vs. 13.6% (3/22), P > 0.05]. The incidence of periventricular-intraventricular hemorrhage (PVH-IVH) in the vibrating mesh atomization technology group was less than that in the INSURE technology group [0% (0/20) vs. 18.2% (4/22)], but no statistical difference was found (P > 0.05). No significant differences in the secondary use rate of PS and incidence of bronchopulmonary dysplasia (BPD) or other complications were found between the vibrating mesh atomization technology group and the INSURE technology group [5.0% (1/20) vs. 9.1% (2/22), 5.0% (1/20) vs. 4.5% (1/22), both P > 0.05]. There were no deaths or serious adverse events such as pneumothorax, pulmonary hemorrhage, periventricular leukomalacia (PVL), retinopathy of prematurity (ROP), and necrotizing enterocolitis (NEC) in both groups. CONCLUSIONS: Compared with the INSURE technique, NCPAP combined with vibrating mesh atomization technology was also effective and safe in the treatment of RDS, which could significantly improve PaO2/FiO2 and shorten the duration of respiratory support. Thus, it was worthy of clinical popularization and application.


Assuntos
Surfactantes Pulmonares , Síndrome do Desconforto Respiratório do Recém-Nascido , Administração por Inalação , Pressão Positiva Contínua nas Vias Aéreas/efeitos adversos , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Nebulizadores e Vaporizadores , Estudos Prospectivos , Surfactantes Pulmonares/administração & dosagem , Surfactantes Pulmonares/efeitos adversos , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico
7.
Arch Dis Child Fetal Neonatal Ed ; 107(2): 156-160, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34413092

RESUMO

OBJECTIVE: The aim of this study was to determine the experience with, and the feasibility of, point-of-view video recordings using eye-tracking glasses for training and reviewing neonatal interventions during the COVID-19 pandemic. DESIGN: Observational prospective single-centre study. SETTING: Neonatal intensive care unit at the Leiden University Medical Center. PARTICIPANTS: All local neonatal healthcare providers. INTERVENTION: There were two groups of participants: proceduralists, who wore eye-tracking glasses during procedures, and observers who later watched the procedures as part of a video-based reflection. MAIN OUTCOME MEASURES: The primary outcome was the feasibility of, and the proceduralists and observers' experience with, the point-of-view eye-tracking videos as an additional tool for bedside teaching and video-based reflection. RESULTS: We conducted 12 point-of-view recordings on 10 different patients (median gestational age of 30.9±3.5 weeks and weight of 1764 g) undergoing neonatal intubation (n=5), minimally invasive surfactant therapy (n=5) and umbilical line insertion (n=2). We conducted nine video-based observations with a total of 88 observers. The use of point-of-view recordings was perceived as feasible. Observers further reported the point-of-view recordings to be an educational benefit for them and a potentially instructional tool during COVID-19. CONCLUSION: We proved the practicability of eye-tracking glasses for point-of-view recordings of neonatal procedures and videos for observation, educational sessions and logistics considerations, especially with the COVID-19 pandemic distancing measures reducing bedside teaching opportunities.


Assuntos
COVID-19/epidemiologia , Tecnologia de Rastreamento Ocular , Unidades de Terapia Intensiva Neonatal , Internato e Residência/métodos , Gravação em Vídeo , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Intubação/métodos , Pandemias , Estudos Prospectivos , Surfactantes Pulmonares/administração & dosagem , SARS-CoV-2
8.
Arch Dis Child Fetal Neonatal Ed ; 107(1): 51-55, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34112722

RESUMO

OBJECTIVE: To evaluate the safety of an aerosolised surfactant, SF-RI 1, administered via nasal continuous positive airway pressure (nCPAP) and a prototype breath synchronisation device (AeroFact), to preterm infants with respiratory distress syndrome (RDS). DESIGN: Multicentre, open-label, dose-escalation study with historical controls. SETTING: Newborn intensive care units at Mater Mothers' Hospital, Brisbane, and Royal Hospital for Women, Sydney, Australia. PATIENTS: Infants 26 weeks through 30 weeks gestation who required nCPAP 6-8 cmH2O and fraction of inspired oxygen (FiO2) <0.30 at <2 hours of age. INTERVENTIONS: In part 1, infants received a single dose of 216 mg/kg of aerosolised surfactant. In part 2, infants could receive up to four doses of aerosolised surfactant. Three historical control infants were matched for each enrolled infant. MAIN OUTCOME MEASURES: Treatment failure was defined as Respiratory Severity Score (FiO2×cmH2O nCPAP) >2.4, nCPAP >8 cmH2O, arterial carbon dioxide >65 mm Hg, pH <7.20 or three severe apnoeas within 6 hours during the first 72 hours of life. Other outcomes included tolerance of the AeroFact treatment and complications of prematurity. RESULTS: 10 infants were enrolled in part 1 and 21 in part 2 and were compared with 93 historical controls. No safety issues were identified. In part 2, 6 of 21 (29%) AeroFact-treated infants compared with 30 of 63 (48%) control infants met failure criteria. Kaplan-Meier analysis of patients in part 2 showed a trend towards decreased rate of study failure in the AeroFact-treated infants compared with historical controls (p=0.10). CONCLUSION: The AeroFact system can safely deliver aerosolised surfactant to preterm infants with RDS who are on nCPAP. TRIAL REGISTRATION NUMBER: ACTRN12617001458325.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas , Sistemas de Liberação de Medicamentos , Fosfolipídeos/administração & dosagem , Surfactantes Pulmonares/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Aerossóis , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Fosfolipídeos/efeitos adversos , Fosfolipídeos/uso terapêutico , Projetos Piloto , Surfactantes Pulmonares/efeitos adversos , Surfactantes Pulmonares/uso terapêutico , Falha de Tratamento
9.
Arch Dis Child Fetal Neonatal Ed ; 107(2): 222-224, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34083353

RESUMO

INTRODUCTION: Less-invasive surfactant administration (LISA) under continuous positive airway pressure is increasingly used for the treatment of neonatal respiratory distress. Different procedures are described, but data on the optimal catheter insertion depth are sparse. OBJECTIVE: To generate data for recommending an optimal catheter insertion depth in LISA. METHODS: We examined 112 anterior-posterior chest X-rays from intubated infants and determined the carina's vertebral projection, whenever possible. After that, distances between the middle of cervical vertebra 4 (C4) and thoracic vertebra 2 and the middle of C4 to thoracic vertebra 3, respectively, were measured. Results were plotted against infant's weight. RESULTS: A weight-based chart and recommendations for the optimal intratracheal catheter position in infants with a body weight between 350 and 4000 g were created. CONCLUSIONS: Generated data offer standardisation and may thus help to find a balance between risk of surfactant reflux and unilateral surfactant administration.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/métodos , Recém-Nascido Prematuro , Intubação Intratraqueal/métodos , Surfactantes Pulmonares/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Vias de Administração de Medicamentos , Humanos , Lactente , Recém-Nascido , Respiração Artificial/métodos
11.
Turk J Med Sci ; 52(6): 1779-1784, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36945972

RESUMO

BACKGROUND: We aimed to discuss term infants who are given surfactant due to respiratory disorder according to the underlying etiology, the dose of surfactant administration, and the need for repeated surfactant administration. METHODS: In this retrospective study infants hospitalized in the 4th level neonatal intensive care unit during January 2019 and December 2021 and administered surfactant due to respiratory distress were included. Term infants given surfactant due to respiratory failure were included in the study through the data recording system. The number of surfactant doses, indications for administration, mortality, duration of hospitalization, intubation time, and inotrope use were recorded in the infants included in the study. RESULTS: : During the two-year period, 1250 infants were hospitalized in our neonatal intensive care unit. Of those, 56 infants received surfactant replacement therapy for severe respiratory failure. There were 30 infants with pneumonia, 4 infants with meconium aspiration syndrome (MAS), and 22 infants with transient tachypnea of the newborn (TTN). It was seen that single-dose administration was higher in patients with TTN (p = 0.01), while multiple-dose surfactant administration was more common in patients with MAS, resulting in a statistical difference (p = 0.02). Mortality was lower, especially in cases given early surfactant administration and this situation was statistically significant (p < 0.001). Duration of intubation was 5.05 ± 4.7 days in early surfactant administration group and 8.0 ± 6.1 days in late surfactant administration group. This difference was statistically significant (p = 0.04). While early surfactant application was statistically higher in the TTN group (p = 0.007), late surfactant application was statistically higher in the pneumonia group (p = 0.001). DISCUSSION: Despite the difference on administration time and repeat dose interval due to etiology, surfactant treatment is improving the respiratory distress of term infants.


Assuntos
Surfactantes Pulmonares , Síndrome do Desconforto Respiratório do Recém-Nascido , Insuficiência Respiratória , Tensoativos , Humanos , Masculino , Feminino , Gravidez , Recém-Nascido , Lactente , Tensoativos/administração & dosagem , Tensoativos/uso terapêutico , Surfactantes Pulmonares/administração & dosagem , Surfactantes Pulmonares/uso terapêutico , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Taquipneia Transitória do Recém-Nascido , Insuficiência Respiratória/tratamento farmacológico , Síndrome de Aspiração de Mecônio , Resultado do Tratamento
12.
JAMA ; 326(24): 2478-2487, 2021 12 28.
Artigo em Inglês | MEDLINE | ID: mdl-34902013

RESUMO

Importance: The benefits of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome are uncertain. Objective: To examine the effect of selective application of MIST at a low fraction of inspired oxygen threshold on survival without bronchopulmonary dysplasia (BPD). Design, Setting, and Participants: Randomized clinical trial including 485 preterm infants with a gestational age of 25 to 28 weeks who were supported with continuous positive airway pressure (CPAP) and required a fraction of inspired oxygen of 0.30 or greater within 6 hours of birth. The trial was conducted at 33 tertiary-level neonatal intensive care units around the world, with blinding of the clinicians and outcome assessors. Enrollment took place between December 16, 2011, and March 26, 2020; follow-up was completed on December 2, 2020. Interventions: Infants were randomized to the MIST group (n = 241) and received exogenous surfactant (200 mg/kg of poractant alfa) via a thin catheter or to the control group (n = 244) and received a sham (control) treatment; CPAP was continued thereafter in both groups unless specified intubation criteria were met. Main Outcomes and Measures: The primary outcome was the composite of death or physiological BPD assessed at 36 weeks' postmenstrual age. The components of the primary outcome (death prior to 36 weeks' postmenstrual age and BPD at 36 weeks' postmenstrual age) also were considered separately. Results: Among the 485 infants randomized (median gestational age, 27.3 weeks; 241 [49.7%] female), all completed follow-up. Death or BPD occurred in 105 infants (43.6%) in the MIST group and 121 (49.6%) in the control group (risk difference [RD], -6.3% [95% CI, -14.2% to 1.6%]; relative risk [RR], 0.87 [95% CI, 0.74 to 1.03]; P = .10). Incidence of death before 36 weeks' postmenstrual age did not differ significantly between groups (24 [10.0%] in MIST vs 19 [7.8%] in control; RD, 2.1% [95% CI, -3.6% to 7.8%]; RR, 1.27 [95% CI, 0.63 to 2.57]; P = .51), but incidence of BPD in survivors to 36 weeks' postmenstrual age was lower in the MIST group (81/217 [37.3%] vs 102/225 [45.3%] in the control group; RD, -7.8% [95% CI, -14.9% to -0.7%]; RR, 0.83 [95% CI, 0.70 to 0.98]; P = .03). Serious adverse events occurred in 10.3% of infants in the MIST group and 11.1% in the control group. Conclusions and Relevance: Among preterm infants with respiratory distress syndrome supported with CPAP, minimally invasive surfactant therapy compared with sham (control) treatment did not significantly reduce the incidence of the composite outcome of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age. However, given the statistical uncertainty reflected in the 95% CI, a clinically important effect cannot be excluded. Trial Registration: anzctr.org.au Identifier: ACTRN12611000916943.


Assuntos
Produtos Biológicos/administração & dosagem , Displasia Broncopulmonar/prevenção & controle , Pressão Positiva Contínua nas Vias Aéreas , Recém-Nascido Prematuro , Fosfolipídeos/administração & dosagem , Surfactantes Pulmonares/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Feminino , Humanos , Recém-Nascido , Doenças do Prematuro/mortalidade , Masculino , Síndrome do Desconforto Respiratório do Recém-Nascido/mortalidade , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Método Simples-Cego
13.
Respir Res ; 22(1): 314, 2021 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-34930247

RESUMO

BACKGROUND: Current criteria for surfactant administration assume that hypoxia is a direct marker of lung-volume de-recruitment. We first introduced an early, non-invasive assessment of lung mechanics by the Forced Oscillation Technique (FOT) and evaluated its role in predicting the need for surfactant therapy. OBJECTIVES: To evaluate whether lung reactance (Xrs) assessment by FOT within 2 h of birth identifies infants who would need surfactant within 24 h; to eventually determine Xrs performance and a cut-off value for early detection of infants requiring surfactant. METHODS: We conducted a prospective, observational, non-randomized study in our tertiary NICU in Milan. Eligible infants were born between 27+0 and 34+6 weeks' gestation, presenting respiratory distress after birth. EXCLUSION CRITERIA: endotracheal intubation at birth, major malformations participation in other interventional trials, parental consent denied. We assessed Xrs during nasal CPAP at 5 cmH2O at 10 Hz within 2 h of life, recording flow and pressure tracing through a Fabian Ventilator for off-line analysis. Clinicians were blinded to FOT results. RESULTS: We enrolled 61 infants, with a median [IQR] gestational age of 31.9 [30.3; 32.9] weeks and birth weight 1490 [1230; 1816] g; 2 infants were excluded from the analysis for set-up malfunctioning. 14/59 infants received surfactant within 24 h. Xrs predicted surfactant need with a cut-off - 33.4 cmH2O*s/L and AUC-ROC = 0.86 (0.76-0.96), with sensitivity 0.85 and specificity 0.83. An Xrs cut-off value of - 23.3 cmH2O*s/L identified infants needing surfactant or respiratory support > 28 days with AUC-ROC = 0.89 (0.81-0.97), sensitivity 0.86 and specificity 0.77. Interestingly, 12 infants with Xrs < - 23.3 cmH2O*s/L (i.e. de-recruited lungs) did not receive surfactant and subsequently required prolonged respiratory support. CONCLUSION: Xrs assessed within 2 h of life predicts surfactant need and respiratory support duration in preterm infants. The possible role of Xrs in improving the individualization of respiratory management in preterm infants deserves further investigation.


Assuntos
Pulmão/fisiopatologia , Surfactantes Pulmonares/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Pressão Positiva Contínua nas Vias Aéreas , Feminino , Seguimentos , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Projetos Piloto , Estudos Prospectivos , Síndrome do Desconforto Respiratório do Recém-Nascido/fisiopatologia
14.
Pediatrics ; 148(5)2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34711678

RESUMO

CONTEXT: Surfactant nebulization (SN) may offer a safe alternative for surfactant administration in respiratory distress syndrome of preterm infants. OBJECTIVE: To evaluate the efficacy of SN for the prevention of early intubation. DATA SOURCES: Medline, Embase, The Cochrane Library, clinicaltrials.gov, published abstracts, and references of relevant articles were searched through March 23, 2021. STUDY SELECTION: Randomized clinical trials of preterm infants <37 weeks' gestation comparing SN with noninvasive respiratory support or intratracheal surfactant application. DATA EXTRACTION: Two reviewers extracted data and assessed risk of bias from included studies separately and blinded. Data were pooled by using a fixed-effects model. Subgroups (gestational age, type of nebulizer, surfactant type, and dosage) were evaluated. Primary outcome was intubation rate at 72 hours after birth. RESULTS: Nine studies recruiting 1095 infants met inclusion criteria. SN compared with standard care significantly reduced intubation rate at 72 hours after birth (226 of 565 infants [40.0%] vs 231 of 434 infants [53.2%]; risk ratio [RR]: 0.73, 95% confidence interval [CI]: 0.63-0.84; number needed to treat: 8; 95% CI: 5-14]). Prespecified subgroup analysis identified important heterogeneity: SN was most effective in infants ≥28 weeks' gestation (RR: 0.70, 95% CI: 0.60-0.82), with a pneumatically driven nebulizer (RR: 0.52, 95% CI: 0.40-0.68) and in infants receiving ≥200 mg/kg and animal-derived surfactant (RR: 0.63, 95% CI: 0.52-0.75). No differences in neonatal morbidities or mortality were identified. LIMITATIONS: Quality of evidence was low owing to risk of bias and imprecision. CONCLUSIONS: SN reduced the intubation rate in preterm infants with a higher efficacy for specific subgroups. There was no difference in relevant neonatal morbidities or mortality.


Assuntos
Intubação Intratraqueal/estatística & dados numéricos , Surfactantes Pulmonares/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Administração por Inalação , Intervalos de Confiança , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Nebulizadores e Vaporizadores , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo
15.
Pediatrics ; 148(4)2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34552000

RESUMO

BACKGROUND AND OBJECTIVES: Many preterm infants stabilized on continuous positive airway pressure (CPAP) at birth require mechanical ventilation (MV) during the first 72 hours of life, which is defined as CPAP failure. Our objective was to decrease CPAP failure in infants ≤29 weeks' gestational age (GA). METHODS: A quality improvement bundle named OPTISURF was implemented for infants ≤29 weeks' GA admitted on CPAP, consisting of stepwise escalation of CPAP and less invasive surfactant administration guided by fractional inspired oxygen concentration ≥0.3. The CPAP failure rate was tracked by using control charts. We compared practice and outcomes of a pre-OPTISURF cohort (January 2017 to September 2018) to a post-OPTISURF cohort (October 2018 to December 2019). RESULTS: Of the 216 infants ≤29 weeks' GA admitted to NICU on CPAP, 125 infants belonged to the pre-OPTISURF cohort (OSC) and 91 to the post-OSC. Compared with the pre-OSC, a higher proportion of infants in the post-OSC received CPAP 7 cm H2O within 4 hours of life (7% vs 32%; P < .01). The post-OSC also had lower rates of CPAP failure (54% vs 11%; P < .01), pneumothoraces (8% vs 1%; P < .03), need for MV (58% vs 31%; P < .01), and patent ductus arteriosus treatment (21% vs 9%; P = .02). Additionally, in a subgroup analysis, CPAP failure was lower in the post-OSC among infants 23 to 26 weeks (79% vs 27%; P < .01) and 27 to 29 weeks' GA (46% vs 3%; P < .01). CONCLUSIONS: Implementation of a quality improvement bundle including CPAP optimization and less invasive surfactant administration decreased CPAP failure and need for MV in preterm infants.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas , Recém-Nascido Prematuro , Surfactantes Pulmonares/administração & dosagem , Catéteres , Desenho de Equipamento , Feminino , Humanos , Lactente Extremamente Prematuro , Recém-Nascido , Intubação Intratraqueal/instrumentação , Masculino , Oxigênio/administração & dosagem , Pacotes de Assistência ao Paciente , Melhoria de Qualidade , Respiração Artificial , Falha de Tratamento
16.
Cutan Ocul Toxicol ; 40(4): 359-364, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34429007

RESUMO

BACKGROUND AND AIM: Retinopathy of prematurity (ROP) is the major ocular problem of preterm infants that occurs with abnormal proliferation of immature retinal vessels. Although pentoxifylline (PTX) was reported to inhibit vasculogenesis and neovascularization in experimental studies, there is no clinical data about the effects of PTX treatment on the development and severity of ROP. This clinical study aimed to investigate the possible effects of PTX on the development of ROP. MATERIALS AND METHODS: A single-centre retrospective study was conducted including preterm infants who were hospitalised in the neonatal intensive care unit between 2015-2017 years. Infants were divided into two groups in terms of PTX administration for adjuvant therapy, as PTX and non-PTX groups. RESULTS: A total of 211 infants were included in the study [gestational age 29 (27-31) weeks, birth weight 1140 (960-1340) g]. From these, 97 infants (46%) were given PTX treatment. The two groups were similar in terms of demographic data and baseline clinical characteristics. Any stage of ROP was detected in 47.4% of infants in the PTX group, which was significantly higher than those in the non-PTX group (27.2%) (p = 0.002). The incidence of advanced-stage ROP in the PTX group (10.3%) was also higher than in the non-PTX group (2.6%) (p = 0.021). Repeated usage of PTX was not found to be related to the development of ROP (p = 0.059). The time of PTX administration was similar between the ROP and no-ROP groups (median; one vs one week, p = 0.825). Surfactant therapy, duration of hospital stay, and PTX treatment were found as significant risk factors for ROP in the logistic regression analysis. CONCLUSIONS: In contrast to the experimental studies and also promising results of PTX treatment in some neonatal morbidities, it may be associated with increased incidence and stage of ROP.


Assuntos
Pentoxifilina/administração & dosagem , Vasos Retinianos/efeitos dos fármacos , Retinopatia da Prematuridade/terapia , Terapia Combinada/métodos , Transfusão de Eritrócitos , Feminino , Idade Gestacional , Humanos , Incidência , Lactente Extremamente Prematuro , Recém-Nascido , Recém-Nascido de muito Baixo Peso , Unidades de Terapia Intensiva Neonatal , Masculino , Oxigênio/administração & dosagem , Surfactantes Pulmonares/administração & dosagem , Vasos Retinianos/crescimento & desenvolvimento , Vasos Retinianos/patologia , Retinopatia da Prematuridade/diagnóstico , Retinopatia da Prematuridade/patologia , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença
17.
Chest ; 160(6): 2178-2186, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34293317

RESUMO

BACKGROUND: Previous research shows that a lung ultrasound score (LUS) can anticipate CPAP failure in neonatal respiratory distress syndrome. RESEARCH QUESTION: Can LUS also predict the need for surfactant replacement? STUDY DESIGN AND METHODS: Multicenter, pragmatic study of preterm neonates who underwent lung ultrasound at birth and those given surfactant by masked physicians, who also were scanned within 24 h from administration. Clinical data and respiratory support variables were recorded. Accuracy of LUS, oxygen saturation to Fio2 ratio, Fio2, and Silverman score for surfactant administration were evaluated using receiver operating characteristic curves. The simultaneous prognostic values of LUS and oxygen saturation to Fio2 ratio for surfactant administration, adjusting for gestational age (GA), were analyzed through a logistic regression model. RESULTS: Two hundred forty infants were enrolled. One hundred eight received at least one dose of surfactant. LUS predicted the first surfactant administration with an area under the receiver operating characteristic curve (AUC) of 0.86 (95% CI, 0.81-0.91), cut off of 9, sensitivity of 0.79 (95% CI, 0.70-0.86), specificity of 0.83 (95% CI, 0.76-0.89), positive predictive value of 0.79 (95% CI, 0.71-0.87), negative predictive value of 0.82 (95% CI, 0.75-0.89), positive likelihood ratio of 4.65 (95% CI, 3.14-6.89), and negative likelihood ratio of 0.26 (95% CI, 0.18-0.37). No significant difference was shown among different GA groups: 25 to 27 weeks' GA (AUC, 0.91; 95% CI, 0.84-0.99), 28 to 30 weeks' GA (AUC, 0.81; 95% CI, 0.72-0.91), and 31 to 33 weeks' GA (AUC, 0.88; 95% CI, 0.79-0.95), respectively. LUS declined significantly within 24 h in infants receiving one surfactant dose. When comparing Fio2, oxygen saturation to Fio2 ratio, LUS, and Silverman scores as criteria for surfactant administration, only the latter showed a significantly poorer performance. The combination of oxygen saturation to Fio2 ratio and LUS showed the highest predictive power, with an AUC of 0.93 (95% CI, 0.89-0.97), regardless of the GA interval. INTERPRETATION: LUS is a reliable criterion to administer the first surfactant dose regardless of GA. Its association with oxygen saturation to Fio2 ratio significantly improves the prediction power for surfactant need.


Assuntos
Recém-Nascido Prematuro , Surfactantes Pulmonares/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/diagnóstico por imagem , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Ultrassonografia/métodos , Feminino , Humanos , Recém-Nascido , Masculino , Saturação de Oxigênio
18.
J Mater Chem B ; 9(35): 6988-6993, 2021 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-34085075

RESUMO

Coronavirus disease 2019 (COVID-19) is an RNA virus-based disease that can be deadly. For critically ill patients, mechanical ventilation is an important life-saving treatment. However, mechanical ventilation shows a trade-off between supporting respiratory function and ventilator-induced lung injury (VILI). Surfactant therapy is a medical administration of exogenous surfactant to supplement or replace deficient or dysfunctional endogenous surfactant. Surfactant therapy can be used to postpone or shorten the use of mechanical ventilation to minimize or avoid VILI, because surfactants can reduce surface tension, improve lung compliance, and enhance oxygenation. In addition, nanotechnology can be applied to improve the therapeutic effect and reduce the adverse effects of surfactants. In this perspective, we discussed how nanoparticles deliver surfactants through intravenous injection and inhalation to the expected lung disease regions where surfactants are mostly needed, and discussed the prospects of nanoparticle-mediated surfactant therapy in the treatment of patients with severe COVID-19.


Assuntos
Tratamento Farmacológico da COVID-19 , Portadores de Fármacos/química , Nanopartículas/química , Surfactantes Pulmonares/uso terapêutico , Administração por Inalação , Animais , Portadores de Fármacos/administração & dosagem , Humanos , Injeções Intravenosas , Pulmão , Nanopartículas/administração & dosagem , Surfactantes Pulmonares/administração & dosagem , Surfactantes Pulmonares/química , SARS-CoV-2
19.
Curr Med Sci ; 41(3): 542-547, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34129204

RESUMO

The present study aimed to examine the effectiveness of bi-level positive airway pressure (BiPAP) versus continuous positive airway pressure (CPAP) in preterm infants with birth weight less than 1500 g and respiratory distress syndrome (RDS) following intubation-surfactant-extubation (INSURE) treatment. A two-center randomized control trial was performed. The primary outcome was the reintubation rate of infants within 72 h of age after INSURE. Secondary outcomes included bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and incidences of adverse events. Lung function at one year of corrected age was also compared between the two groups. There were 140 cases in the CPAP group and 144 in the BiPAP group. After INSURE, the reintubation rates of infants within 72 h of age were 15% and 11.1% in the CPAP group and the BiPAP group, respectively (P>0.05). Neonates in the BiPAP group was on positive airway pressure (PAP) therapy three days less than in the CPAP group (12.6 d and 15.3 d, respectively, P<0.05), and on oxygen six days less than in the CPAP group (20.6 d and 26.9 d, respectively, P<0.05). Other outcomes such as BPD, NEC, ROP and feeding intolerance were not significantly different between the two groups (P>0.05). There was no difference in lung function at one year of age between the two groups (P>0.05). In conclusion, after INSURE, the reintubation rate of infants within 72 h of age was comparable between the BiPAP group and the CPAP group. BiPAP was superior to CPAP in terms of shorter durations (days) on PAP support and oxygen supplementation. There were no differences in the incidences of BPD and ROP, and lung function at one year of age between the two ventilation methods.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/métodos , Recém-Nascido de Baixo Peso/crescimento & desenvolvimento , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Adulto , Extubação , Peso ao Nascer , Pressão Positiva Contínua nas Vias Aéreas/efeitos adversos , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro/crescimento & desenvolvimento , Masculino , Surfactantes Pulmonares/administração & dosagem
20.
Ital J Pediatr ; 47(1): 129, 2021 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-34082803

RESUMO

BACKGROUND: Neonatal respiratory distress syndrome (NRDS) is strongly associated with premature birth, but it can also affect term neonates. Unlike the extent of research in preterm neonates, risk factors associated with incidence and severity of NRDS in term neonates are not well studied. In this study, we examined the association of maternal and neonatal risk factors with the incidence and severity of NRDS in term neonates admitted to Neonatal Intensive Care Unit (NICU) in Cyprus. METHODS: In a prospective, case-control design we recruited term neonates with NRDS and non-NRDS admitted to the NICU of Archbishop Makarios III hospital, the only neonatal tertiary centre in Cyprus, between April 2017-October 2018. Clinical data were obtained from patients' files. We used univariate and multivariate logistic and linear regression models to analyse binary and continuous outcomes respectively. RESULTS: During the 18-month study period, 134 term neonates admitted to NICU were recruited, 55 (41%) with NRDS diagnosis and 79 with non-NRDS as controls. In multivariate adjusted analysis, male gender (OR: 4.35, 95% CI: 1.03-18.39, p = 0.045) and elective caesarean section (OR: 11.92, 95% CI: 1.80-78.95, p = 0.01) were identified as independent predictors of NRDS. Among neonates with NRDS, early-onset infection tended to be associated with increased administration of surfactant (ß:0.75, 95% CI: - 0.02-1.52, p = 0.055). Incidence of pulmonary hypertension or systemic hypotension were associated with longer duration of parenteral nutrition (pulmonary hypertension: 11Vs 5 days, p < 0.001, systemic hypotension: 7 Vs 4 days, p = 0.01) and higher rate of blood transfusion (pulmonary hypertension: 100% Vs 67%, p = 0.045, systemic hypotension: 85% Vs 55%, p = 0.013). CONCLUSIONS: This study highlights the role of elective caesarean section and male gender as independent risk factors for NRDS in term neonates. Certain therapeutic interventions are associated with complications during the course of disease. These findings can inform the development of evidence-based recommendations for improved perinatal care.


Assuntos
Síndrome do Desconforto Respiratório do Recém-Nascido/epidemiologia , Estudos de Casos e Controles , Cesárea/estatística & dados numéricos , Chipre/epidemiologia , Feminino , Humanos , Recém-Nascido , Masculino , Gravidez , Estudos Prospectivos , Surfactantes Pulmonares/administração & dosagem , Fatores de Risco , Fatores Sexuais , Nascimento a Termo
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