RESUMO
In the PDA-TOLERATE trial, persistent (even for several weeks) moderate to large patent ductus arteriosus (PDA) was not associated with an increased risk of BPD when the infant required <10 days of intubation. However, in infants requiring intubation for ≥10 days, prolonged PDA exposure (≥11 days) was associated with an increased risk of moderate/severe BPD.
Assuntos
Displasia Broncopulmonar/etiologia , Permeabilidade do Canal Arterial/terapia , Intubação Intratraqueal/efeitos adversos , Intubação Intratraqueal/métodos , Respiração Artificial , Displasia Broncopulmonar/epidemiologia , Permeabilidade do Canal Arterial/complicações , Feminino , Humanos , Recém-Nascido , Masculino , Estudos Prospectivos , Índice de Gravidade de Doença , Fatores de TempoRESUMO
The PDA: TO LEave it alone or Respond And Treat Early trial compared the effects of 2 strategies for treatment of patent ductus arteriosus (PDA) in infants <280/7 weeks of gestation; however 137 potentially eligible infants were not recruited and received treatment of their PDA outside the PDA-TOLERATE trial due to "lack-of-physician-equipoise" (LPE). Despite being less mature and needing more respiratory support, infants with LPE had lower rates of mortality than enrolled infants. Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01958320.
Assuntos
Esquema de Medicação , Permeabilidade do Canal Arterial/tratamento farmacológico , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Displasia Broncopulmonar/complicações , Feminino , Humanos , Lactente Extremamente Prematuro , Recém-Nascido de Baixo Peso , Recém-Nascido , Doenças do Prematuro/terapia , Masculino , Idade Materna , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Risco , Resultado do TratamentoRESUMO
OBJECTIVE: To compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given. STUDY DESIGN: A total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.1 weeks) with moderate-to-large PDA shunts were enrolled between age 6 and 14 days (mean, 8.1 ± 2.2 days) into an exploratory randomized controlled trial. RESULTS: At enrollment, 49% of the patients were intubated and 48% required nasal ventilation or continuous positive airway pressure. There were no differences between the groups in either our primary outcome of ligation or presence of a PDA at discharge (early routine treatment [ERT], 32%; conservative treatment [CT], 39%) or any of our prespecified secondary outcomes of necrotizing enterocolitis (ERT, 16%; CT, 19%), bronchopulmonary dysplasia (BPD) (ERT, 49%; CT, 53%), BPD/death (ERT, 58%; CT, 57%), death (ERT,19%; CT, 10%), and weekly need for respiratory support. Fewer infants in the ERT group met the rescue criteria (ERT, 31%; CT, 62%). In secondary exploratory analyses, infants receiving ERT had significantly less need for inotropic support (ERT, 13%; CT, 25%). However, among infants who were ≥26 weeks gestational age, those receiving ERT took significantly longer to achieve enteral feeding of 120 mL/kg/day (median: ERT, 14 days [range, 4.5-19 days]; CT, 6 days [range, 3-14 days]), and had significantly higher incidences of late-onset non-coagulase-negative Staphylococcus bacteremia (ERT, 24%; CT,6%) and death (ERT, 16%; CT, 2%). CONCLUSIONS: In preterm infants age <28 weeks with moderate-to-large PDAs who were receiving respiratory support after the first week, ERT did not reduce PDA ligations or the presence of a PDA at discharge and did not improve any of the prespecified secondary outcomes, but delayed full feeding and was associated with higher rates of late-onset sepsis and death in infants born at ≥26 weeks of gestation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01958320.
Assuntos
Acetaminofen/uso terapêutico , Tratamento Conservador , Inibidores de Ciclo-Oxigenase/uso terapêutico , Permeabilidade do Canal Arterial/terapia , Ibuprofeno/uso terapêutico , Indometacina/uso terapêutico , Pressão Positiva Contínua nas Vias Aéreas , Permeabilidade do Canal Arterial/classificação , Feminino , Idade Gestacional , Humanos , Lactente Extremamente Prematuro , Recém-Nascido , Masculino , Estudos Prospectivos , Método Simples-Cego , Resultado do TratamentoRESUMO
OBJECTIVE: To test the hypothesis that an impaired adrenal response to stress might play a role in the hypotension that follows patent ductus arteriosus (PDA) ligation. STUDY DESIGN: We performed a multicenter study of infants born at <32 weeks' gestation who were about to undergo PDA ligation. Serum adrenal steroids were measured 3 times: before and after a cosyntropin (1.0 µg/kg) stimulation test (performed before the ligation), and at 10-12 hours after the ligation. A standardized approach for diagnosis and treatment of postoperative hypotension was followed at each site. A modified inotrope score (1 × dopamine [µg/kg/min] + 1 × dobutamine) was used to monitor the catecholamine support an infant received. Infants were considered to have catecholamine-resistant hypotension if their greatest inotrope score was >15. RESULTS: Of 95 infants enrolled, 43 (45%) developed hypotension and 14 (15%) developed catecholamine-resistant hypotension. Low postoperative cortisol levels were not associated with the overall incidence of hypotension after ligation. However, low cortisol levels were associated with the refractoriness of the hypotension to catecholamine treatment. In a multivariate analysis: the OR for developing catecholamine-resistant hypotension was OR 36.6, 95% CI 2.8-476, P = .006. Low cortisol levels (in infants with catecholamine-resistant hypotension) were not attributable to adrenal immaturity or impairment; their cortisol precursor concentrations were either low or unchanged, and their response to cosyntropin was similar to infants without catecholamine-resistant hypotension. CONCLUSION: Infants with low cortisol concentrations after PDA ligation are likely to develop postoperative catecholamine-resistant hypotension. We speculate that decreased adrenal stimulation, rather than an impaired adrenal response to stimulation, may account for the decreased production.
Assuntos
Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Catecolaminas/administração & dosagem , Permeabilidade do Canal Arterial/cirurgia , Hidrocortisona/sangue , Hipotensão/etiologia , Recém-Nascido Prematuro , Hormônio Adrenocorticotrópico/metabolismo , Procedimentos Cirúrgicos Cardíacos/métodos , Estudos de Coortes , Resistência a Medicamentos , Permeabilidade do Canal Arterial/diagnóstico , Permeabilidade do Canal Arterial/mortalidade , Feminino , Seguimentos , Humanos , Hipotensão/tratamento farmacológico , Hipotensão/fisiopatologia , Recém-Nascido , Ligadura/efeitos adversos , Ligadura/métodos , Masculino , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/tratamento farmacológico , Cuidados Pré-Operatórios/métodos , Estudos Retrospectivos , Medição de Risco , Taxa de SobrevidaRESUMO
OBJECTIVE: To compare the efficacy and safety of volume-controlled (VC) ventilation to time-cycled pressure-limited (TCPL) ventilation in very low birth weight infants with respiratory distress syndrome (RDS). STUDY DESIGN: Newborns weighing between 600 and 1500 g and with a gestational age of 24 to 31 weeks who had RDS were randomized to receive either VC or TCPL ventilation and treated with a standardized protocol. The 2 modalities were compared by determining the time required to achieve a predetermined success criterion, on the basis of either the alveolar-arterial oxygen gradient <100 mm Hg or the mean airway pressure <8 cm H(2)O. Secondary outcomes included mortality, duration of mechanical ventilation, and complications commonly associated with ventilation. RESULTS: The mean time to reach the success criterion was 23 hours in the VC group versus 33 hours in the TCPL group (P = .15). This difference was more striking in babies weighing <1000g (21 versus 58 hours; P = .03). Mean duration of ventilation with VC was 255 hours versus 327 hours with TCPL (P = .60). There were 5 deaths in the VC group and 10 deaths in the TCPL group (P = .10). The incidence of other complications was similar. CONCLUSION: VC ventilation is safe and efficacious in very low birth weight infants and may have advantages when compared with TCPL, especially in smaller infants.