Condotta di attesa o ibuprofene precoce nei gravi prematuri con dotto arterioso pervio: potrebbe essere meglio fare meno

Abstract

Wait-and- see or early ibuprofen in severe preterm infants with a patent ductus arteriosus: maybe less is better In preterm infants, persistence of the pervious ductus arteriosus is associated with increased neonatal mortality and morbidity, bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) and intraventricular hemorrhage (IVH), however, a causal relationship is not proven and the usefulness, timing and modalities of pharmacological treatment aimed at closure are still debated. In this noninferiority, multicenter, open-label study, 273 infants of gestational age <28 sg, with pda diameter>1.5 mm and left-right shunt, were randomized to receive wait-and-see management or early treatment with ibuprofen. A composite primary outcome including necrotizing enterocolitis, moderate to severe bronchopulmonary dysplasia, or death assessed at the chronological age of 36 weeks was evaluated. A primary outcome event occurred in 63 of 136 infants (46.3%) in the wait-and-see conduct group and in 87 of 137 (63.5%) in the ibuprofen group (absolute risk difference, -17.2 percentage points; upper margin 95% confidence interval [CI], -7.4; P<0.001 for non-inferiority). The authors conclude that the expected conduct for PDA in severely premature infants is non-inferior to early treatment with ibuprofen compared with necrotizing enterocolitis, moderate to severe bronchopulmonary dysplasia, or death at chronological age 36 weeks. Some limitations of the study are discussed: lower numerosity than required for the non-inferiority limit (half of the calculated patients were enrolled), open-label treatment allowed in prespecified cases in the wait-and-see group, composite outcome driven substantially by the high incidence of bronchopulmonary dysplasia in the ibuprofen group, non-inclusion of intraventricular hemorrhage in the primary outcome. Respiratory sleep disorders (SDB) affect about 12% of children. An Australian multicenter, randomized, double-blind, placebo-controlled clinical trial, conducted in tertiary care centers, aims to test the efficacy of intranasal mometasone in improving symptoms and quality of life of children with SDB compared an intranasal saline solution. A total of 276 subjects aged 3 to 12 years with SDB were recruited. The results show no difference between the two treatments. In fact, in both groups there is an equal percentage of improvement in symptoms, a fact that could be due in both groups to the treatment or to the natural evolution. This leads the authors to state that a proportion of children with SDB could be managed in the primary care setting.