RESUMEN
A single dose of synthetic surfactant was administered prophylactically to premature neonates with birth weights between 700 and 1100 gm. The effects of this treatment on neurodevelopmental, neurologic, and ophthalmologic outcomes, impairments, and general health status were examined during a follow-up evaluation at 1-year adjusted age. The study was a multicenter, parallel, randomized, double-blind comparison of 446 infants who received either air placebo (n = 222) or synthetic surfactant (n = 224). Follow-up evaluations were completed for 82% of surviving infants in both treatment groups. Neurodevelopmental outcome and growth were equivalent in the infants treated with synthetic surfactant and in the infants given air placebo. Impairments occurred in 38% of the infants treated with air placebo compared with 31% of those given synthetic surfactant; the difference was not statistically significant (relative risk 0.809, 95% confidence interval 0.585, 1.119). The incidence of asthma was significantly higher in the group of infants given air placebo (4% vs 10% for surfactant and air placebo, respectively, relative risk 0.391, 95% confidence intervals 0.157, 0.972). Other outcomes, including retinopathy of prematurity, hospital readmissions, surgery, and evidence of chronic lung disease, were not different. Administration of a single prophylactic dose of synthetic surfactant increases survival in infants with birth weights between 700 and 110 gm without increasing the number or proportion of impaired survivors.
Asunto(s)
Alcoholes Grasos/uso terapéutico , Recién Nacido de Bajo Peso , Fosforilcolina , Polietilenglicoles/uso terapéutico , Surfactantes Pulmonares/uso terapéutico , Síndrome de Dificultad Respiratoria del Recién Nacido/prevención & control , Aire , Desarrollo Infantil , Enfermedad Crónica , Método Doble Ciego , Combinación de Medicamentos , Femenino , Estudios de Seguimiento , Estado de Salud , Hospitalización , Humanos , Lactante , Recién Nacido , Enfermedades Pulmonares/epidemiología , Masculino , Examen Neurológico , Desempeño Psicomotor , Retinopatía de la Prematuridad/epidemiologíaRESUMEN
In a multicenter, double-blind, placebo-controlled trial conducted at 23 hospitals in the United States, a single prophylactic 5 ml/kg dose of a synthetic surfactant (Exosurf Neonatal) or air placebo was administered shortly after birth to 215 infants with birth weights of 500 to 699 gm. Despite stratification at entry by birth weight and gender, by chance female infants predominated in the air placebo group and male infants predominated in the surfactant group. Among infants receiving synthetic surfactant, improvements in oxygen requirements were significant at 2 hours after birth (p = 0.014) and persisted for 3 days (p = 0.001); improvements in the alveolar-arterial partial pressure of oxygen gradient were significant at 6 hours after birth (p = 0.01) and persisted for 3 days (p = 0.008). Improvements in mean airway pressure were not significant at 2 or at 6 hours after birth (p = 0.622 and 0.083, respectively), but became significant thereafter and persisted for 3 days (p = 0.002). Pneumothorax was reduced by slightly more than half (25 vs 11; p = 0.014); death from respiratory distress syndrome (RDS) was also reduced (26 vs 15; p = 0.046). Overall neonatal mortality, however, was not significantly reduced (58 vs 46; p = 0.102). Other complications of RDS and prematurity were not altered, except that pulmonary hemorrhage occurred significantly more frequently in infants receiving synthetic surfactant (2 vs 12; p = 0.006). These findings indicate that a single prophylactic dose of synthetic surfactant in infants weighing 500 to 699 gm at birth improves lung function, incidence of air leak, and death from RDS but not overall mortality. The only safety problem identified was an increase in pulmonary hemorrhage.
Asunto(s)
Alcoholes Grasos/uso terapéutico , Enfermedades del Prematuro/prevención & control , Fosforilcolina , Polietilenglicoles/uso terapéutico , Surfactantes Pulmonares/uso terapéutico , Displasia Broncopulmonar/prevención & control , Hemorragia Cerebral/prevención & control , Método Doble Ciego , Combinación de Medicamentos , Conducto Arterioso Permeable/prevención & control , Femenino , Humanos , Recién Nacido de Bajo Peso , Recién Nacido , Recien Nacido Prematuro , Enfermedades del Prematuro/mortalidad , Masculino , Síndrome de Dificultad Respiratoria del Recién Nacido/prevención & control , Análisis de SupervivenciaRESUMEN
Although necrotizing enterocolitis has been associated with polycythemia in human infants, a causal relationship has not been established. Forty-six unanesthetized puppies were studied (age 6 to 14 days). Normovolemic polycythemia (Hct 0.70) was induced in 19 pups by exchange transfusion with 75 ml/kg packed red blood cells. Hypervolemic polycythemia (Hct 0.70) was induced in 14 pups by transfusion with 50 ml/kg RBC. Thirteen pups received exchange transfusion with whole blood and served as controls (Hct 0.40). Gross autopsy was performed on all pups 24 hours after transfusion or at death. Necrotizing enterocolitis was defined as areas of violaceous discoloration of the bowel associated with blood in the intestinal lumen. Although lesions appeared throughout the bowel in some pups, involvement of the distal small bowel was most common. Diagnosis was confirmed by microscopic examination. Both gross and microscopic lesions appeared similar to those in necrotizing enterocolitis in human infants. The disorder was seen in 11 of 19 pups with normovolemic polycythemia, eight of 14 pups with hypervolemic polycythemia, and only one of 13 control animals (P less than 0.01). Polycythemia can cause necrotizing enterocolitis in the newborn dog.