RESUMEN
BACKGROUND: It is current practice for physicians to use the Prontosan® range of products in children based on their personal clinical experience, despite the lack of safety data in this population. This retrospective data review was designed to obtain information on the safety profile of the Prontosan® range of products in children in routine clinical practice. METHODS: Data from newborns, infants and children with burns treated with the Prontosan® range were collected retrospectively from patient medical records. RESULTS: The majority of children treated for burns (80.1%) were under the age of four. More boys than girls were subject to burn injury (58.1% vs. 41.9%). The majority of burns (74.7%) were partial thickness burn (IIa and IIb). Safety was analysed based on the adverse events/reactions, infections and interactions/symptoms related to Prontosan® reported in the CRFs. AEs were reported in five children after the use of Prontosan® products: itching (3 cases), rash (1 case) and hypergranulating tissue (1 case). No event was severe and all events resolved favourably with good healing results. In addition, 11 patients developed clinical signs of infection during treatment (mainly Staphylococcus aureus). CONCLUSIONS: The Prontosan® range of products is demonstrated as safe and tolerable for use in children as part of burn treatment. Inclusion of this range of products in the protocol of paediatric burn care allows a good healing process starting with appropriate wound cleansing and maintaining moist wound environment.
Asunto(s)
Biguanidas/farmacología , Quemaduras/tratamiento farmacológico , Cicatrización de Heridas/efectos de los fármacos , Adolescente , Vendajes/normas , Biguanidas/uso terapéutico , Niño , Preescolar , Desinfectantes/farmacología , Desinfectantes/uso terapéutico , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Pediatría/instrumentación , Pediatría/métodos , Pediatría/normas , Estudios RetrospectivosRESUMEN
Among obstetricians and neonatologists in administrative roles in New York City hospitals, a survey was initiated to compare the physicians' definitions of live birth and fetal death, the gestational age at which they consider infants viable, and the resuscitation practices of the neonatologists. The target survey population was 34 neonatologists, and 39 obstetricians representing 41 of the City's 43 maternity hospitals. A telephone survey was used to gather qualitative data from the physicians regarding their definitions of live birth, fetal death, and viability, and their practices regarding extremely premature births. Surveys were completed for 58 physicians, a response rate of 79% (94% for neonatologists and 67% for obstetricians). Physicians' definitions of live birth and fetal death varied, with almost a third (29%) of physicians including gestational age as part of their live birth criteria. Most of the physicians (90%) consider infants born at ≥23 weeks gestation viable. Most neonatologists (97%) said they always resuscitate infants born at ≥23 weeks gestation, and most (94%) said they would never resuscitate infants born at <20 weeks gestation. For infants born at 20-22 weeks gestation, there were differences in resuscitation practices. There is a gap between clinical practices and reporting requirements for live birth and fetal death. Whereas reporting requirements are based on definitions of live birth and fetal death, physicians make resuscitation and other clinical decisions regarding extremely premature infants based on definitions of viability.