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1.
Telemed J E Health ; 29(4): 617-620, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36067146

RESUMEN

Introduction: The early acute phase of the coronavirus disease 2019 pandemic created rapid adaptation in health care delivery. Methods: Using electronic medical record data from two different institutions located in two different states, we examined how telemedicine was integrated into obstetric care. Results: With no telemedicine use prior, both institutions rapidly incorporated telemedicine into prenatal care (PNC). There were significant patient-level and institutional-level differences in telemedicine use. Telemedicine users initiated PNC earlier and had more total visits, earlier timing of ultrasounds, and earlier diabetes screening during pregnancy compared with nonusers. There were no significant differences in delivery mode or stillbirth associated with telemedicine use at either institution. Conclusions: Rapid adoption of obstetric telemedicine maintained adequate prenatal care provision during the early pandemic, but implementation varied across institutions.


Asunto(s)
COVID-19 , Telemedicina , Embarazo , Femenino , Humanos , COVID-19/epidemiología , SARS-CoV-2 , Pandemias/prevención & control , Atención Prenatal
2.
Curr Opin Pediatr ; 34(2): 191-196, 2022 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-35102115

RESUMEN

PURPOSE OF REVIEW: Neonatal lymphatic disorders (NLDs) are conditions that are relatively rare and difficult to treat. The recent development of lymphatic imaging, such as Dynamic Contrast-Enhanced MR Lymphangiography and Intranodal Lymphangiography has led to a new, better understanding of the anatomical substrate and pathophysiological mechanisms of the diseases. Consequently, this has allowed the development of new targeted therapeutic interventions as well as prognostication for this population with lymphatic flow disorders. RECENT FINDINGS: The underlying causes of all NLD is an obstruction or altered flow of the central lymphatic flow. Two types of NLD have been described: isolated neonatal chylothorax and central lymphatic flow disorder (CLFD). Isolated neonatal chylothorax can be treated successfully with oil-based contrast (lipiodol) embolization. CLFD secondary to obstruction of the thoraco-venous junction can be successfully treated with surgical thoracic duct-venous anastomosis. CLFD caused by elevated central pressure and/or thoracic duct dysplasia can be treated medically, including with new systemic therapies such as mammalian target of rapamycin inhibitors. SUMMARY: New diagnostic and interventional tools have recently allowed for classification, prognostication, and targeted interventions for neonatal patients with lymphatic flow disorders. Further research will build on these discoveries.


Asunto(s)
Quilotórax , Embolización Terapéutica , Enfermedades Linfáticas , Quilotórax/diagnóstico por imagen , Quilotórax/terapia , Embolización Terapéutica/efectos adversos , Embolización Terapéutica/métodos , Humanos , Recién Nacido , Enfermedades Linfáticas/terapia , Linfografía/efectos adversos , Linfografía/métodos , Imagen por Resonancia Magnética/métodos
3.
Adv Neonatal Care ; 22(3): 203-209, 2022 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-34407057

RESUMEN

BACKGROUND: Timely central venous access is essential in the care of critically ill neonates. Peripherally inserted central catheters (PICCs) are the preferred form of central venous access when umbilical venous catheters cannot be placed or are discontinued. However, time delays increase risk for injury from peripheral intravenous lines and may contribute to inconsistent delivery of necessary fluids and medications. PURPOSE: The aim of this quality improvement project was to decrease wait times for PICC placement in the neonatal intensive care unit (NICU). METHODS: A unit-based PICC team was developed consisting of NICU nurses and attending neonatologists and implemented in 2 phases. Data were collected from chart reviews before, during, and after implementation of the team. We tracked time between PICC order and placement and number of attempts. Hospital metrics on peripheral intravenous line infiltrations and central line-associated blood stream infection were also monitored. At the end of the project, we continued tracking outcomes to determine whether gains would be sustained past the project period. RESULTS: Implementation of a unit-based interdisciplinary specialty team led to a 50% reduction in mean PICC wait times from 1.2 days to 0.58 days. Benefits of the initiative were sustained past the initial project period. IMPLICATIONS FOR PRACTICE: The development of a dedicated, local team played a key role in improving vascular access in the NICU. IMPLICATIONS FOR RESEARCH: Proximity of specialized teams provides a solution to address gaps in care in the NICU.


Asunto(s)
Infecciones Relacionadas con Catéteres , Cateterismo Venoso Central , Cateterismo Periférico , Infecciones Relacionadas con Catéteres/prevención & control , Cateterismo Venoso Central/efectos adversos , Cateterismo Periférico/efectos adversos , Humanos , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Mejoramiento de la Calidad , Estudios Retrospectivos
4.
Am J Respir Crit Care Med ; 200(6): 751-759, 2019 09 15.
Artículo en Inglés | MEDLINE | ID: mdl-30995069

RESUMEN

Rationale: Current diagnostic criteria for bronchopulmonary dysplasia rely heavily on the level and duration of oxygen therapy, do not reflect contemporary neonatal care, and do not adequately predict childhood morbidity.Objectives: To determine which of 18 prespecified, revised definitions of bronchopulmonary dysplasia that variably define disease severity according to the level of respiratory support and supplemental oxygen administered at 36 weeks' postmenstrual age best predicts death or serious respiratory morbidity through 18-26 months' corrected age.Methods: We assessed infants born at less than 32 weeks of gestation between 2011 and 2015 at 18 centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network.Measurements and Main Results: Of 2,677 infants, 683 (26%) died or developed serious respiratory morbidity. The diagnostic criteria that best predicted this outcome defined bronchopulmonary dysplasia according to treatment with the following support at 36 weeks' postmenstrual age, regardless of prior or current oxygen therapy: no bronchopulmonary dysplasia, no support (n = 773); grade 1, nasal cannula ≤2 L/min (n = 1,038); grade 2, nasal cannula >2 L/min or noninvasive positive airway pressure (n = 617); and grade 3, invasive mechanical ventilation (n = 249). These criteria correctly predicted death or serious respiratory morbidity in 81% of study infants. Rates of this outcome increased stepwise from 10% among infants without bronchopulmonary dysplasia to 77% among those with grade 3 disease. A similar gradient (33-79%) was observed for death or neurodevelopmental impairment.Conclusions: The definition of bronchopulmonary dysplasia that best predicted early childhood morbidity categorized disease severity according to the mode of respiratory support administered at 36 weeks' postmenstrual age, regardless of supplemental oxygen use.


Asunto(s)
Displasia Broncopulmonar/diagnóstico , Displasia Broncopulmonar/fisiopatología , Medicina Basada en la Evidencia/métodos , Enfermedades del Prematuro/diagnóstico , Enfermedades del Prematuro/fisiopatología , Pediatría/métodos , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro , Recién Nacido de muy Bajo Peso , Masculino , Estados Unidos
5.
J Physiol ; 596(9): 1575-1585, 2018 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-29392729

RESUMEN

KEY POINTS: Bronchopulmonary dysplasia is a disease of extreme prematurity that occurs when the immature lung is exposed to gas ventilation. We designed a novel 'artificial womb' system for supporting extreme premature lambs (called EXTEND) that obviates gas ventilation by providing oxygen via a pumpless arteriovenous circuit with the lamb submerged in sterile artificial amniotic fluid. In the present study, we compare different arteriovenous cannulation strategies on EXTEND, including carotid artery/jugular vein (CA/JV), carotid artery/umbilical vein (CA/UV) and umbilical artery/umbilical vein (UA/UV). Compared to CA/JV and CA/UV cannulation, UA/UV cannulation provided significantly higher, physiological blood flows to the oxygenator, minimized flow interruptions and supported significantly longer circuit runs (up to 4 weeks). Physiological circuit blood flow in UA/UV lambs made possible normal levels of oxygen delivery, which is a critical step toward the clinical application of artificial womb technology. ABSTRACT: EXTEND (EXTra-uterine Environment for Neonatal Development) is a novel system that promotes physiological development by maintaining the premature lamb in a sterile fluid environment and providing gas exchange via a pumpless arteriovenous oxygenator circuit. During the development of EXTEND, different cannulation strategies evolved with the aim of improving circuit flow. The present study examines how different cannulation strategies affect EXTEND circuit haemodynamics in extreme premature lambs. Seventeen premature lambs were cannulated at gestational ages 105-117 days (term 145-150 days) and supported on EXTEND for up to 4 weeks. Experimental groups were distinguished by cannulation strategy: carotid artery outflow and jugular vein inflow (CA/JV; n = 4), carotid artery outflow and umbilical vein inflow (CA/UV; n = 5) and double umbilical artery outflow and umbilical vein inflow (UA/UV; n = 8). Circuit flows and pressures were measured continuously. As we transitioned from CA/JV to CA/UV to UA/UV cannulation, mean duration of circuit run and weight-adjusted circuit flows increased (P < 0.001) and the frequency of flow interruptions declined (P < 0.05). Umbilical vessels generally accommodated larger-bore cannulas, and cannula calibre was directly correlated with circuit pressures and indirectly correlated with flow:pressure ratio (a measure of post-membrane resistance). We conclude that UA/UV cannulation in fetal lambs on EXTEND optimizes circuit flow dynamics and flow stability and also supports circuit flows that closely approximate normal placental flow.


Asunto(s)
Cateterismo/métodos , Hemodinámica , Pulmón/crecimiento & desarrollo , Oxígeno/metabolismo , Nacimiento Prematuro/terapia , Arterias Umbilicales/fisiología , Venas Umbilicales/fisiología , Animales , Animales Recién Nacidos , Femenino , Pulmón/fisiología , Placenta/fisiología , Embarazo , Nacimiento Prematuro/fisiopatología , Ovinos , Ventilación
6.
J Pediatr ; 194: 60-66.e1, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29269198

RESUMEN

OBJECTIVE: To characterize the epidemiology of Car Seat Tolerance Screening (CSTS) failure and the association between test failure and all-cause 30-day postdischarge mortality or hospital readmission in a large, multicenter cohort of preterm infants receiving neonatal intensive care. STUDY DESIGN: This retrospective cohort study used the prospectively collected Optum Neonatal Database. Study infants were born at <37 weeks of gestation between 2010 and 2016. We identified independent predictors of CSTS failure and calculated the risk-adjusted odds of all-cause 30-day mortality or hospital readmission associated with test failure. RESULTS: Of 7899 infants cared for in 788 hospitals, 334 (4.2%) failed initial CSTS. Greater postmenstrual age at testing and African American race were independently associated with decreased failure risk. Any treatment with an antacid medication, concurrent use of caffeine or supplemental oxygen, and a history of failing a trial off respiratory support were associated with increased failure risk. The mean adjusted post-CSTS duration of hospitalization was 3.1 days longer (95% CI, 2.7-3.6) among the infants who failed the initial screening. Rates of 30-day all-cause mortality or readmission were higher among infants who failed the CSTS (2.4% vs 1.0%; P = .03); however, the difference was not significant after confounder adjustment (OR, 0.38; 95% CI, 0.11-1.31). CONCLUSION: CSTS failure was associated with longer post-test hospitalization but no difference in the risk-adjusted odds for 30-day mortality or hospital readmission. Whether CSTS failure unnecessarily prolongs hospitalization or results in appropriate care that prevents adverse postdischarge outcomes is unknown. Further research is needed to address this knowledge gap.


Asunto(s)
Apnea/diagnóstico , Sistemas de Retención Infantil/efectos adversos , Unidades de Cuidado Intensivo Neonatal , Tamizaje Masivo , Apnea/etiología , Apnea/mortalidad , Hospitalización , Humanos , Recién Nacido , Recien Nacido Prematuro , Estudios Retrospectivos , Factores de Riesgo
7.
J Natl Med Assoc ; 110(2): 163-168, 2018 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-29580450

RESUMEN

BACKGROUND: Pregnant women with sickle cell disease (SCD) are at increased risk of maternal and fetal complications. There are limited data on the outcome of the treatment of VOCs with opioids in relation to neonatal complications during pregnancy. METHODS: This is a retrospective cohort study of women with SCD from January 1999 to December 2008. Women with SCD were identified by ICD-9 codes and matched 2:1 to a control group of women on methadone for opioid dependence. The primary outcome was the rate of neonatal abstinence syndrome (NAS). Secondary outcomes included the mean NAS score prior to treatment and the length of treatment. Statistical analysis was performed using SPSS. RESULTS: Twenty-one women with SCD who delivered a total of 23 neonates were included. The rate of NAS among infants born to women with SCD who were treated with opioids at any time was 22% compared to 54% in the methadone controls (p = .010). The rate of NAS was 27% among infants born to women taking opioids daily compared to 54% in the methadone control group (p = .062). CONCLUSIONS: Neonates born to women with SCD who are treated with daily opioids are at a similar risk for developing NAS as those born to mothers on methadone for opioid dependence. Neonates born to women with SCD treated with episodic opioids are at a significantly lower risk for developing NAS than those born to women on methadone for opioid dependence.


Asunto(s)
Analgésicos Opioides/uso terapéutico , Anemia de Células Falciformes/complicaciones , Metadona/uso terapéutico , Síndrome de Abstinencia Neonatal/epidemiología , Trastornos Relacionados con Opioides/tratamiento farmacológico , Dolor/tratamiento farmacológico , Adulto , Analgésicos Opioides/efectos adversos , Estudios de Casos y Controles , Femenino , Humanos , Incidencia , Tratamiento de Sustitución de Opiáceos , Dolor/etiología , Philadelphia/epidemiología , Embarazo , Complicaciones del Embarazo/tratamiento farmacológico , Complicaciones del Embarazo/etiología , Estudios Retrospectivos , Factores de Riesgo , Adulto Joven
8.
J Pediatr ; 186: 34-40.e2, 2017 07.
Artículo en Inglés | MEDLINE | ID: mdl-28258737

RESUMEN

OBJECTIVE: To assess the association between prophylactic indomethacin and bronchopulmonary dysplasia (BPD) in a recent, large cohort of extremely preterm infants. STUDY DESIGN: Retrospective cohort study using prospectively collected data for infants with gestational ages < 29 weeks or birth weights of 401-1000 g born between 2008 and 2012 at participating hospitals of the National Institute of Child Health and Human Development Neonatal Research Network. Infants treated with indomethacin in the first 24 hours of life were compared with those who were not. Study outcomes were BPD, defined as use of supplemental oxygen at 36 weeks postmenstrual age among survivors to that time point, death, and the composite of death or BPD. Prespecified subgroup analyses were performed. RESULTS: Prophylactic indomethacin use varied by hospital. Treatment of a patent ductus arteriosus after the first day of life was less common among 2587 infants who received prophylactic indomethacin compared with 5244 who did not (21.0% vs 36.1%, P < .001). After adjustment for potential confounders, use of prophylactic indomethacin was not associated with higher or lower odds of BPD (OR 0.89, 95% CI 0.72-1.10), death (OR 0.80, 95% CI 0.64-1.01), or death or BPD (OR 0.87, 95% CI 0.71-1.05). The only evidence of subgroup effects associated with prophylactic indomethacin were lower odds of death among infants with birth weights above the 10th percentile and those who were not treated for a patent ductus arteriosus after the first day of life. CONCLUSIONS: Prophylactic indomethacin was not associated with either reduced or increased risk for BPD or death. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00063063.


Asunto(s)
Antiinflamatorios no Esteroideos/uso terapéutico , Displasia Broncopulmonar/prevención & control , Indometacina/uso terapéutico , Factores de Edad , Femenino , Humanos , Recien Nacido Extremadamente Prematuro , Recién Nacido , Masculino , Terapia por Inhalación de Oxígeno , Estudios Retrospectivos , Resultado del Tratamiento
9.
Am J Perinatol ; 34(1): 96-104, 2017 01.
Artículo en Inglés | MEDLINE | ID: mdl-27285471

RESUMEN

Objective Bacterial colonization of the airway may contribute to the development of bronchopulmonary dysplasia. Whether airway colonization increases risk for later adverse respiratory outcomes is less clear. We described tracheal aspirate culture results obtained from preterm infants receiving mechanical ventilation at 36 weeks postmenstrual age (PMA) and evaluated the association between bacteria type and the risk for prolonged supplemental oxygen use. Study Design We conducted a retrospective, single-center cohort study comparing infants (1) with and without a tracheal aspirate culture that grew a Gram-negative rod (GNR) and (2) with and without a culture that grew a Gram-positive cocci (GPC). Results Among 121 infants, 65 (53.7%) and 51 (42.2%) had a tracheal aspirate culture that grew a potentially pathogenic GNR and GPC prior to 36 weeks PMA, respectively. GNR were associated with increased risk for death or use of supplemental oxygen at discharge (adjusted odds ratio [aOR], 6.2; 95% confidence interval [CI], 1.8-21.1), and use of supplemental oxygen at discharge among survivors (aOR, 5.5; 95% CI, 1.6-19.0). GPC did not affect the risk for any study outcomes. Conclusion GNR but not GPC in the airways of preterm infants receiving mechanical ventilation at 36 weeks PMA is associated with increased risk for prolonged supplemental oxygen use.


Asunto(s)
Displasia Broncopulmonar/epidemiología , Infecciones por Bacterias Gramnegativas/epidemiología , Infecciones por Bacterias Grampositivas/epidemiología , Respiración Artificial , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Estudios de Cohortes , Femenino , Edad Gestacional , Bacterias Gramnegativas/aislamiento & purificación , Infecciones por Bacterias Gramnegativas/microbiología , Infecciones por Bacterias Grampositivas/microbiología , Cocos Grampositivos/aislamiento & purificación , Humanos , Lactante , Recien Nacido Extremadamente Prematuro , Recién Nacido , Recien Nacido Prematuro , Recién Nacido de muy Bajo Peso , Masculino , Oportunidad Relativa , Terapia por Inhalación de Oxígeno , Alta del Paciente , Muerte Perinatal , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Tráquea/microbiología
10.
J Pediatr ; 173: 50-55.e1, 2016 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-27004673

RESUMEN

OBJECTIVE: To determine differences in the incidence of bronchopulmonary dysplasia (BPD) or death in extremely low birth weight infants managed on high flow nasal cannula (HFNC) vs continuous positive airway pressure (CPAP). STUDY DESIGN: This is a retrospective data analysis from the Alere Neonatal Database for infants born between January 2008 and July 2013, weighing ≤1000 g at birth, and received HFNC or CPAP. Baseline demographics, clinical characteristics, and neonatal outcomes were compared between the infants who received CPAP and HFNC, or HFNC ± CPAP. Multivariable regression analysis was performed to control for the variables that differ in bivariate analysis. RESULTS: A total of 2487 infants met the inclusion criteria (941 CPAP group, 333 HFNC group, and 1546 HFNC ± CPAP group). The primary outcome of BPD or death was significantly higher in the HFNC group (56.8%) compared with the CPAP group (50.4%, P < .05). Similarly, adjusted odds of developing BPD or death was greater in the HFNC ± CPAP group compared with the CPAP group (OR 1.085, 95% CI 1.035-1.137, P = .001). The number of ventilator days, postnatal steroid use, days to room air, days to initiate or reach full oral feeds, and length of hospitalization were significantly higher in the HFNC and HFNC ± CPAP groups compared with the CPAP group. CONCLUSIONS: In this retrospective study, use of HFNC in extremely low birth weight infants is associated with a higher risk of death or BPD, increased respiratory morbidities, delayed oral feeding, and prolonged hospitalization. A large clinical trial is needed to evaluate long-term safety and efficacy of HFNC in preterm infants.


Asunto(s)
Displasia Broncopulmonar/epidemiología , Recien Nacido con Peso al Nacer Extremadamente Bajo , Tiempo de Internación/estadística & datos numéricos , Terapia por Inhalación de Oxígeno/efectos adversos , Terapia por Inhalación de Oxígeno/métodos , Presión de las Vías Aéreas Positiva Contínua , Utilización de Medicamentos , Femenino , Glucocorticoides/uso terapéutico , Mortalidad Hospitalaria , Humanos , Lactante , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Masculino , Estudios Retrospectivos , Factores de Tiempo , Estados Unidos/epidemiología
11.
Am J Perinatol ; 33(10): 939-44, 2016 08.
Artículo en Inglés | MEDLINE | ID: mdl-27057767

RESUMEN

Objective The objective of this study was to determine differences in the incidence of bronchopulmonary dysplasia (BPD) or death in very low-birth-weight (VLBW) infants managed successfully on continuous positive airway pressure (CPAP) versus mechanical ventilation on the first day of life (DOL). Study Design This is a retrospective analysis of the Alere neonatal database for infants born between January 2009 and December 2014, weighing ≤ 1,500 g. Baseline demographics, clinical characteristics, and outcomes were compared between the two groups. Multivariable regression analysis was performed to control the variables that differ in bivariate analysis. Results In this study, 4,629 infants (birth weight 1,034 ± 290 g, gestational age 28.1 ± 2.5 weeks) met the inclusion criteria. The successful use of early CPAP was associated with a significant reduction in BPD or death (p < 0.001), as well as days to room air, decreased oxygen use at discharge, lower risk for severe intraventricular hemorrhage, and patent ductus arteriosus requiring surgical ligation (p < 0.001 for all outcomes). Conclusion Successful use of early CPAP on the first DOL in VLBW infants is associated with a reduced risk of BPD or death.


Asunto(s)
Displasia Broncopulmonar/epidemiología , Presión de las Vías Aéreas Positiva Contínua/métodos , Recien Nacido con Peso al Nacer Extremadamente Bajo , Recien Nacido Extremadamente Prematuro , Respiración Artificial/métodos , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Hemorragia Cerebral/epidemiología , Conducto Arterioso Permeable/epidemiología , Femenino , Edad Gestacional , Humanos , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Modelos Logísticos , Masculino , Análisis Multivariante , Síndrome de Dificultad Respiratoria del Recién Nacido/complicaciones , Estudios Retrospectivos , Factores de Tiempo , Estados Unidos
12.
JAMA ; 312(24): 2629-39, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-25536254

RESUMEN

IMPORTANCE: Hypothermia at 33.5°C for 72 hours for neonatal hypoxic ischemic encephalopathy reduces death or disability to 44% to 55%; longer cooling and deeper cooling are neuroprotective in animal models. OBJECTIVE: To determine if longer duration cooling (120 hours), deeper cooling (32.0°C), or both are superior to cooling at 33.5°C for 72 hours in neonates who are full-term with moderate or severe hypoxic ischemic encephalopathy. DESIGN, SETTING, AND PARTICIPANTS: A randomized, 2 × 2 factorial design clinical trial performed in 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network between October 2010 and November 2013. INTERVENTIONS: Neonates were assigned to 4 hypothermia groups; 33.5°C for 72 hours, 32.0°C for 72 hours, 33.5°C for 120 hours, and 32.0°C for 120 hours. MAIN OUTCOMES AND MEASURES: The primary outcome of death or disability at 18 to 22 months is ongoing. The independent data and safety monitoring committee paused the trial to evaluate safety (cardiac arrhythmia, persistent acidosis, major vessel thrombosis and bleeding, and death in the neonatal intensive care unit [NICU]) after the first 50 neonates were enrolled, then after every subsequent 25 neonates. The trial was closed for emerging safety profile and futility analysis after the eighth review with 364 neonates enrolled (of 726 planned). This report focuses on safety and NICU deaths by marginal comparisons of 72 hours' vs 120 hours' duration and 33.5°C depth vs 32.0°C depth (predefined secondary outcomes). RESULTS: The NICU death rates were 7 of 95 neonates (7%) for the 33.5°C for 72 hours group, 13 of 90 neonates (14%) for the 32.0°C for 72 hours group, 15 of 96 neonates (16%) for the 33.5°C for 120 hours group, and 14 of 83 neonates (17%) for the 32.0°C for 120 hours group. The adjusted risk ratio (RR) for NICU deaths for the 120 hours group vs 72 hours group was 1.37 (95% CI, 0.92-2.04) and for the 32.0°C group vs 33.5°C group was 1.24 (95% CI, 0.69-2.25). Safety outcomes were similar between the 120 hours group vs 72 hours group and the 32.0°C group vs 33.5°C group, except major bleeding occurred among 1% in the 120 hours group vs 3% in the 72 hours group (RR, 0.25 [95% CI, 0.07-0.91]). Futility analysis determined that the probability of detecting a statistically significant benefit for longer cooling, deeper cooling, or both for NICU death was less than 2%. CONCLUSIONS AND RELEVANCE: Among neonates who were full-term with moderate or severe hypoxic ischemic encephalopathy, longer cooling, deeper cooling, or both compared with hypothermia at 33.5°C for 72 hours did not reduce NICU death. These results have implications for patient care and design of future trials. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01192776.


Asunto(s)
Hipotermia Inducida , Hipoxia-Isquemia Encefálica/terapia , Unidades de Cuidado Intensivo Neonatal , Acidosis/etiología , Arritmias Cardíacas/etiología , Discapacidades del Desarrollo , Femenino , Hemorragia/etiología , Humanos , Hipotermia Inducida/efectos adversos , Lactante , Recién Nacido , Masculino , Análisis de Supervivencia , Temperatura , Trombosis/etiología , Factores de Tiempo
13.
Trials ; 25(1): 201, 2024 Mar 20.
Artículo en Inglés | MEDLINE | ID: mdl-38509583

RESUMEN

BACKGROUND: Invasive mechanical ventilation contributes to bronchopulmonary dysplasia (BPD), the most common complication of prematurity and the leading respiratory cause of childhood morbidity. Non-invasive ventilation (NIV) may limit invasive ventilation exposure and can be either synchronized or non-synchronized (NS). Pooled data suggest synchronized forms may be superior. Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) delivers NIV synchronized to the neural signal for breathing, which is detected with a specialized catheter. The DIVA (Diaphragmatic Initiated Ventilatory Assist) trial aims to determine in infants born 240/7-276/7 weeks' gestation undergoing extubation whether NIV-NAVA compared to non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV) reduces the incidence of extubation failure within 5 days of extubation. METHODS: This is a prospective, unblinded, pragmatic, multicenter phase III randomized clinical trial. Inclusion criteria are preterm infants 24-276/7 weeks gestational age who were intubated within the first 7 days of life for at least 12 h and are undergoing extubation in the first 28 postnatal days. All sites will enter an initial run-in phase, where all infants are allocated to NIV-NAVA, and an independent technical committee assesses site performance. Subsequently, all enrolled infants are randomized to NIV-NAVA or NS-NIPPV at extubation. The primary outcome is extubation failure within 5 days of extubation, defined as any of the following: (1) rise in FiO2 at least 20% from pre-extubation for > 2 h, (2) pH ≤ 7.20 or pCO2 ≥ 70 mmHg; (3) > 1 apnea requiring positive pressure ventilation (PPV) or ≥ 6 apneas requiring stimulation within 6 h; (4) emergent intubation for cardiovascular instability or surgery. Our sample size of 478 provides 90% power to detect a 15% absolute reduction in the primary outcome. Enrolled infants will be followed for safety and secondary outcomes through 36 weeks' postmenstrual age, discharge, death, or transfer. DISCUSSION: The DIVA trial is the first large multicenter trial designed to assess the impact of NIV-NAVA on relevant clinical outcomes for preterm infants. The DIVA trial design incorporates input from clinical NAVA experts and includes innovative features, such as a run-in phase, to ensure consistent technical performance across sites. TRIAL REGISTRATION: www. CLINICALTRIALS: gov , trial identifier NCT05446272 , registered July 6, 2022.


Asunto(s)
Soporte Ventilatorio Interactivo , Ventilación no Invasiva , Lactante , Recién Nacido , Humanos , Ventilación con Presión Positiva Intermitente/efectos adversos , Recien Nacido Extremadamente Prematuro , Soporte Ventilatorio Interactivo/efectos adversos , Soporte Ventilatorio Interactivo/métodos , Extubación Traqueal/efectos adversos , Estudios Prospectivos , Ventilación no Invasiva/efectos adversos , Ventilación no Invasiva/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto , Ensayos Clínicos Fase III como Asunto
14.
Neonatology ; 120(5): 633-641, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37573771

RESUMEN

OBJECTIVES: Inhaled nitric oxide (iNO) is an effective pulmonary vasodilator. However, the efficacy of iNO in former premature infants with established bronchopulmonary dysplasia (BPD) has not been studied. This study aimed to determine the efficacy of iNO in reducing pulmonary artery pressure in infants with severe BPD as measured by echocardiography. STUDY DESIGN: Prospective, observational study enrolling infants born at less than 32 weeks gestation and in whom (1) iNO therapy was initiated after admission to our institution, or (2) at the outside institution less than 48 h before transfer and received an echocardiogram prior to iNO initiation, and (3) had severe BPD. Data were collected at three time-points: (1) before iNO; (2) 12-48 h after initiation of iNO; and (3) 48-168 h after initiation of iNO. The primary outcome was the effect of iNO on pulmonary artery pressure measured by echocardiography in patients with severe BPD between 48 and 168 h after initiating iNO therapy. RESULTS: Of 37 enrolled, 81% had echocardiographic evidence of pulmonary arterial hypertension (PAH) before iNO and 56% after 48 h of iNO (p = 0.04). FiO2 requirements were significantly different between time-points (1) and (3) (p = 0.05). There were no significant differences between Tricuspid Annular Plane Systolic Excursion (TAPSE) Z-Scores, time to peak velocity: right ventricular ejection time (TPV:RVET), and ventilator changes. CONCLUSIONS: Although we found a statistically significant reduction of PAH between time-point (1) and (3), future trials are needed to further guide clinical care.


Asunto(s)
Displasia Broncopulmonar , Hipertensión Arterial Pulmonar , Recién Nacido , Humanos , Lactante , Óxido Nítrico , Displasia Broncopulmonar/diagnóstico por imagen , Displasia Broncopulmonar/tratamiento farmacológico , Hipertensión Arterial Pulmonar/tratamiento farmacológico , Estudios Prospectivos , Administración por Inhalación , Ecocardiografía
15.
JAMA Netw Open ; 6(5): e2312277, 2023 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-37155165

RESUMEN

Importance: Meta-analyses suggest that corticosteroids may be associated with increased survival without cerebral palsy in infants at high risk of bronchopulmonary dysplasia (BPD) but are associated with adverse neurologic outcomes in low-risk infants. Whether this association exists in contemporary practice is uncertain because most randomized clinical trials administered corticosteroids earlier and at higher doses than currently recommended. Objective: To evaluate whether the pretreatment risk of death or grade 2 or 3 BPD at 36 weeks' postmenstrual age modified the association between postnatal corticosteroid therapy and death or disability at 2 years' corrected age in extremely preterm infants. Design, Setting, and Participants: This cohort study analyzed data on 482 matched pairs of infants from 45 participating US hospitals in the National Institute of Child Health and Human Development Neonatal Research Network Generic Database (GDB). Infants were included in the cohort if they were born at less than 27 weeks' gestation between April 1, 2011, and March 31, 2017; survived the first 7 postnatal days; and had 2-year death or developmental follow-up data collected between January 2013 and December 2019. Corticosteroid-treated infants were propensity score matched with untreated controls. Data were analyzed from September 1, 2019, to November 30, 2022. Exposure: Systemic corticosteroid therapy to prevent BPD that was initiated between day 8 and day 42 after birth. Main Outcomes and Measures: The primary outcome was death or moderate to severe neurodevelopmental impairment at 2 years' corrected age. The secondary outcome was death or moderate to severe cerebral palsy at 2 years' corrected age. Results: A total of 482 matched pairs of infants (mean [SD] gestational age, 24.1 [1.1] weeks]; 270 males [56.0%]) were included from 656 corticosteroid-treated infants and 2796 potential controls. Most treated infants (363 [75.3%]) received dexamethasone. The risk of death or disability associated with corticosteroid therapy was inversely associated with the estimated pretreatment probability of death or grade 2 or 3 BPD. The risk difference for death or neurodevelopmental impairment associated with corticosteroids decreased by 2.7% (95% CI, 1.9%-3.5%) for each 10% increase in the pretreatment risk of death or grade 2 or 3 BPD. This risk transitioned from estimated net harm to benefit when the pretreatment risk of death or grade 2 or 3 BPD exceeded 53% (95% CI, 44%-61%). For death or cerebral palsy, the risk difference decreased by 3.6% (95% CI, 2.9%-4.4%) for each 10% increase in the risk of death or grade 2 or 3 BPD and transitioned from estimated net harm to benefit at a pretreatment risk of 40% (95% CI, 33%-46%). Conclusions and Relevance: Results of this study suggested that corticosteroids were associated with a reduced risk of death or disability in infants at moderate to high pretreatment risk of death or grade 2 or 3 BPD but with possible harm in infants at lower risk.


Asunto(s)
Displasia Broncopulmonar , Parálisis Cerebral , Adulto , Niño , Preescolar , Humanos , Lactante , Recién Nacido , Masculino , Adulto Joven , Displasia Broncopulmonar/etiología , Parálisis Cerebral/epidemiología , Parálisis Cerebral/complicaciones , Estudios de Cohortes , Dexametasona/uso terapéutico , Glucocorticoides/uso terapéutico , Recien Nacido Extremadamente Prematuro
18.
J Perinat Neonatal Nurs ; 26(2): 166-71, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-22551865

RESUMEN

The Apgar score is a standardized tool for evaluating newborns in the delivery room. Despite its long history and widespread use, debate remains over its reliability of predicting neonatal outcomes, especially in extremely low-birth-weight premature infants. The aim of the study was to examine the relationship between the 5-minute Apgar score of extremely low-birth-weight infants, as it relates to survival and morbidities associated with prematurity and length of hospital stay. A retrospective query of the Alere neonatal database from 2001 to 2011 examined all infants less than 32 weeks' gestation and less than 1000-g birth weight. The 5-minute Apgar score was divided into 2 groups, score of 4 or greater or less than 4. The study compared results of the 5-minute Apgar score and associated morbidities in surviving infants. Statistical analyses included chi-square, Fisher exact test, t test, and multivariate regression. The sample consisted of 3898 infants with an 86.4% (n = 3366) survival rate. Controlling for gestational age and birth weight, surviving infants with a 5-minute Apgar score of less than 4 were more likely to demonstrate nonintact survival. Infants with a low 5-minute Apgar score have greater risk for mortality and morbidities associated with prematurity.


Asunto(s)
Puntaje de Apgar , Indicadores de Salud , Recien Nacido con Peso al Nacer Extremadamente Bajo , Enterocolitis Necrotizante/epidemiología , Humanos , Recién Nacido , Hemorragias Intracraneales/epidemiología , Tiempo de Internación , Leucomalacia Periventricular/epidemiología , Lesión Pulmonar/epidemiología , Análisis Multivariante , Pronóstico , Retinopatía de la Prematuridad/epidemiología , Estudios Retrospectivos , Tasa de Supervivencia , Estados Unidos/epidemiología
19.
Obstet Gynecol ; 139(3): 381-390, 2022 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-35115443

RESUMEN

OBJECTIVE: To compare postpartum hospitalization length of stay (LOS) and hospital readmission among obstetric patients before (March 2017-February 2020; prepandemic) and during the coronavirus disease 2019 (COVID-19) pandemic (March 2020-February 2021). METHODS: We conducted a retrospective cohort study, using Epic Systems' Cosmos research platform, of obstetric patients who delivered between March 1, 2017, and February 28, 2021, at 20-44 weeks of gestation and were discharged within 7 days of delivery. The primary outcome was short postpartum hospitalization LOS (less than two midnights for vaginal births and less than three midnights for cesarean births) and secondary outcome was hospital readmission within 6 weeks of postpartum hospitalization discharge. Analyses compared outcomes before and during the pandemic using standardized differences and Bayesian logistic mixed-effects models, among all births and stratified by mode of delivery. RESULTS: Of the 994,268 obstetric patients in the study cohort, 742,113 (74.6%) delivered prepandemic and 252,155 (25.4%) delivered during the COVID-19 pandemic. During the COVID-19 pandemic, the percentage of short postpartum hospitalizations increased among all births (28.7-44.5%), vaginal births (25.4-39.5%), and cesarean births (35.3-55.1%), which was consistent with the adjusted analysis (all births: adjusted odds ratio [aOR] 2.35, 99% credible interval 2.32-2.39; vaginal births: aOR 2.14, 99% credible interval 2.11-2.18; cesarean births aOR 2.90, 99% credible interval 2.83-2.98). Although short postpartum hospitalizations were more common during the COVID-19 pandemic, there was no change in readmission in the unadjusted (1.4% vs 1.6%, standardized difference=0.009) or adjusted (aOR 1.02, 99% credible interval 0.97-1.08) analyses for all births or when stratified by mode of delivery. CONCLUSION: Short postpartum hospitalization LOS was significantly more common during the COVID-19 pandemic for obstetric patients with no change in hospital readmissions within 6 weeks of postpartum hospitalization discharge. The COVID-19 pandemic created a natural experiment, suggesting shorter postpartum hospitalization may be reasonable for patients who are self-identified or health care professional-identified as appropriate for discharge.


Asunto(s)
COVID-19 , Tiempo de Internación/estadística & datos numéricos , Readmisión del Paciente/estadística & datos numéricos , Atención Posnatal/estadística & datos numéricos , Adolescente , Adulto , Femenino , Humanos , Periodo Posparto , Embarazo , Estudios Retrospectivos , Adulto Joven
20.
Pediatrics ; 149(1)2022 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-34889449

RESUMEN

OBJECTIVES: To determine if birth hospitalization length of stay (LOS) and infant rehospitalization changed during the coronavirus disease 2019 (COVID-19) era among healthy, term infants. METHODS: Retrospective cohort study using Epic's Cosmos data from 35 health systems of term infants discharged ≤5 days of birth. Short birth hospitalization LOS (vaginal birth <2 midnights; cesarean birth <3 midnights) and, secondarily, infant rehospitalization ≤7 days after birth hospitalization discharge were compared between the COVID-19 (March 1 to August 31, 2020) and prepandemic eras (March 1 to August 31, 2017, 2018, 2019). Mixed-effects models were used to estimate adjusted odds ratios (aORs) comparing the eras. RESULTS: Among 202 385 infants (57 110 from the COVID-19 era), short birth hospitalization LOS increased from 28.5% to 43.0% for all births (vaginal: 25.6% to 39.3%, cesarean: 40.1% to 61.0%) during the pandemic and persisted after multivariable adjustment (all: aOR 2.30, 95% confidence interval [CI] 2.25-2.36; vaginal: aOR 2.12, 95% CI 2.06-2.18; cesarean: aOR 3.01, 95% CI 2.87-3.15). Despite shorter LOS, infant rehospitalizations decreased slightly during the pandemic (1.2% to 1.1%); results were similar in adjusted analysis (all: aOR 0.83, 95% CI 0.76-0.92; vaginal: aOR 0.82, 95% CI 0.74-0.91; cesarean: aOR 0.87, 95% CI 0.69-1.10). There was no change in the proportion of rehospitalization diagnoses between eras. CONCLUSIONS: Short infant LOS was 51% more common in the COVID-19 era, yet infant rehospitalization within a week did not increase. This natural experiment suggests shorter birth hospitalization LOS among family- and clinician-selected, healthy term infants may be safe with respect to infant rehospitalization, although examination of additional outcomes is needed.


Asunto(s)
COVID-19/prevención & control , Tiempo de Internación/tendencias , Readmisión del Paciente/tendencias , Pautas de la Práctica en Medicina/tendencias , Nacimiento a Término , Femenino , Humanos , Recién Nacido , Masculino , Embarazo , Estudios Retrospectivos , Estados Unidos
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