RESUMO
OBJECTIVE: To compare the efficacy and safety of two surfactant preparations in the treatment of respiratory distress syndrome (RDS). METHODS: We conducted a randomized, masked comparison trial at 21 centers. Infants with RDS who were undergoing mechanical ventilation were eligible for treatment with two doses of either a synthetic (Exosurf) or natural (Infasurf) surfactant if the ratio of arterial to alveolar partial pressure of oxygen was less than or equal to 0.22. Crossover treatment was allowed within 96 hours of age if severe respiratory failure (defined as two consecutive arterial/alveolar oxygen tension ratios < or = 0.10) persisted after two doses of the randomly assigned surfactant. Four primary outcome measures of efficacy (the incidence of pulmonary air leak (< or = 7 days); the severity of RDS; the incidence of death from RDS; and the incidence of survival without bronchopulmonary dysplasia (BPD) at 28 days after birth) were compared by means of linear regression techniques. RESULTS: The primary analysis of efficacy was performed in 1033 eligible infants and an analysis of safety outcomes in the 1126 infants who received study surfactant. Preentry demographic characteristics and respiratory status were similar for the two treatment groups, except for a small but significant difference in mean gestational age (0.5 week) that favored the infasurf treatment group. Pulmonary air leak (< or = 7 days) occurred in 21% of Exosurf- and 11% of infasurf-treated infants (adjusted relative risk, 0.53; 95% confidence interval, 0.40 to 0.71; p < or = 0.0001). During the 72 hours after the initial surfactant treatment, the average fraction of inspired oxygen (+/-SEM) was 0.47 +/- 0.01 for Exosurf- and 0.39 +/- 0.01 for infasurf-treated infants (difference, 0.08; 95% confidence interval, 0.06 to 0.10; p < 0.0001); the average mean airway pressure (+/-SEM) was 8.6 +/- 0.1 cm H2O; for Exosurf- and 7.2 +/- 0.1 cm H2O for Infasurf-treated infants (difference, 1.4 cm H2O; 95% confidence interval, 1.0 to 1.8 cm H2O; p < 0.0001). The incidences of RDS-related death, total respiratory death, death to discharge, and survival without bronchopulmonary dysplasia at 28 days after birth did not differ. The number of days of more than 30% inspired oxygen and of assisted ventilation, but not the duration of hospitalization, were significantly lower in Infasurf-treated infants. CONCLUSION: Compared with Exosurf, Infasurf provided more effective therapy for RDS as assessed by significant reductions in the severity of respiratory disease and in the incidence of air leak complications.
Assuntos
Fosforilcolina , Surfactantes Pulmonares/uso terapêutico , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Displasia Broncopulmonar/epidemiologia , Estudos Cross-Over , Combinação de Medicamentos , Álcoois Graxos/uso terapêutico , Humanos , Incidência , Recém-Nascido , Tempo de Internação , Modelos Lineares , Pneumotórax/epidemiologia , Polietilenoglicóis/uso terapêutico , Enfisema Pulmonar/epidemiologia , Respiração Artificial , Síndrome do Desconforto Respiratório do Recém-Nascido/mortalidade , Taxa de Sobrevida , Fatores de Tempo , Resultado do TratamentoRESUMO
A case series design was used to identify cases of cystic periventricular leukomalacia (N = 31) identified by neurosonography at one regional tertiary intensive care nursery. Patients were preterm infants born at < or = 32 weeks of gestation who had cysts involving predominantly the middle-posterior or posterior periventricular regions. Neurodevelopmental evaluations were made for 26 (96%) of 27 survivors. All infants assessed had cerebral palsy (i.e., 54% quadriplegia, 42% diplegia, and 4% hemiplegia). Most cognitive delays and all sensory impairments occurred in children with quadriplegia. Periventricular cysts were most extensive on parasagittal, anteroposterior views. The parasagittal, anteroposterior extent of periventricular cysts was most accurate in predicting the type and severity of motor and cognitive disabilities. Quadriplegia was associated with larger and more extensive cysts.
Assuntos
Paralisia Cerebral/etiologia , Leucomalácia Periventricular/complicações , Paralisia Cerebral/classificação , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Leucomalácia Periventricular/diagnóstico por imagem , Leucomalácia Periventricular/patologia , Masculino , UltrassonografiaRESUMO
We reviewed clinical data in 33 patients with transient hyperammonemia of the newborn (THAN): six previously unreported cases and 27 from the literature. Thirteen neonates with urea cycle enzyme deficiencies (UCED) served for comparison. No differences were found in the incidence of perinatal complications, route of delivery, Apgar scores, sex, or incidence or time of onset of seizures. On the other hand, neonates with THAN had significantly lower birth weights (mean +/- SEM 2282 +/- 78 gm vs 3336 +/- 222 gm, P less than 0.001) and gestational ages (35.1 +/- 0.5 weeks vs 39.6 +/- 0.5 weeks, P less than 0.001). Mean time of onset of respiratory distress (3.9 +/- 1.4 hours vs 71.5 +/- 26.1 hours, P less than 0.001), ventilatory support (P less than 0.001), lethargy (P less than 0.005), and coma (P less than 0.005) occurred earlier in THAN. Distinctive laboratory findings in patients with THAN included abnormal chest radiographic findings and plasma ammonium concentrations that were higher (1871 +/- 209 microM vs 973 +/- 169 microM, P less than 0.02) at an earlier age. Respiratory distress occurred in all but one patient with THAN before 24 hours; in contrast, only 62% of infants with UCED had respiratory symptoms, and none before 30 hours. In this retrospective study, the clinical presentation alone differentiated THAN from UCED.