RESUMO
We assessed the effectiveness of lyophilised banked human milk (HM) as a fortifier to feed very-low-birth-weight infants (VLBWI). This study aimed to evaluate the safety and tolerability of HM with HM lyophilisate as an additive compared with the standard additive (cows' milk protein). In this phase I double-blind randomised controlled clinical trial, set in the intensive and intermediate care units of a tertiary hospital, forty VLBWI were enrolled and allocated into two groups: HM plus HM lyophilisate (LioNeo) or HM plus commercial additive (HMCA). The inclusion criteria were preterm infants, birth weight 750-1500 g, small or adequate for gestational age, exclusively receiving donor HM, volume ≥ 100 ml/kg per d and haemodynamically stable. Participants were followed up for 21 consecutive days. The primary outcome measures were necrotising enterocolitis (NEC), late-onset sepsis (LOS), death, gastrointestinal (GI) bleeding or perforation, diarrhoea, regurgitation, vomiting and abdominal distension. The LioNeo and HMCA groups had similar weights at baseline. The regression models showed no differences between the groups in terms of the primary outcomes. Diarrhoea, GI perforation, NEC and LOS were absent in the LioNeo group (one LOS and one NEC in the HMCA group). Multiple regression analysis with the total volume of milk as a covariate did not show significant differences. The lyophilisation of donor HM was considered safe and tolerable for use in stable haemodynamically VLBWI.
Assuntos
Enterocolite Necrosante , Sepse , Lactente , Animais , Feminino , Bovinos , Recém-Nascido , Humanos , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Leite Humano , Peso ao Nascer , DiarreiaRESUMO
BACKGROUND: The inhibition of gastric acid secretion with ranitidine is frequently prescribed off-label to newborns admitted to neonatal intensive care units (NICU). Some studies show that the use of inhibitors of gastric acid secretion (IGAS) may predispose to infections and necrotising enterocolitis (NEC), but there are few data to confirm this association. This study aimed to compare the rates of neonatal infections and NEC among preterm infants (<37 weeks gestation) hospitalised in a NICU exposed or not to treatment with ranitidine. METHODS: A retrospective cohort study was conducted with all consecutive preterm newborns admitted to a NICU between August-2014 and October-2015. The rates of infection, NEC, and death of newborns exposed or not to ranitidine were recorded. RESULTS: A total of 300 newborns were enrolled, of which 115 had received ranitidine and 185 had not. The two groups were similar with regard to the main demographic and clinical characteristics. Forty-eight (41.7%) of the 115 infants exposed to ranitidine and 49 (26.5%) of the 185 infants not exposed were infected (RR = 1.6, 95%CI 1.1-2.2, p = 0.006). The late onset (>48 h) blood culture positive infection rate was higher in the group exposed to ranitidine than in the untreated group (13.0% vs. 3.8%, p = 0.001). There was no significant association between the use of ranitidine and NEC (Bell stage >II) (p = 0.36). The mortality rate risk was 4-fold higher in infants receiving ranitidine (16.5% vs. 8.6%, p < 0.001). CONCLUSION: Ranitidine use in neonates was associated with an increased risk of infections and mortality, but not with NEC.
Assuntos
Infecção Hospitalar/epidemiologia , Enterocolite Necrosante/epidemiologia , Ranitidina/efeitos adversos , Adulto , Brasil/epidemiologia , Estudos de Coortes , Infecção Hospitalar/induzido quimicamente , Infecção Hospitalar/etiologia , Enterocolite Necrosante/induzido quimicamente , Enterocolite Necrosante/etiologia , Feminino , Idade Gestacional , Mortalidade Hospitalar , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Masculino , Ranitidina/administração & dosagem , Ranitidina/uso terapêutico , Estudos RetrospectivosRESUMO
BACKGROUND: Necrotizing enterocolitis is the most frequent and severe acquired gastrointestinal disease in newborns and still has high mortality. There are few published papers about prognostic factors of death in our country. OBJECTIVE: To know the factors associated with death in patients with necrotizing enterocolitis. METHODS: Retrospective, descriptive, comparative study with a case-control design was conducted on patients with necrotizing enterocolitis during a 5-year period. RESULTS: Deceased patients had significantly lower platelet counts compared to survivors (P=0.022) and the prognostic factors associated with mortality were anaemia (P=0.006, OR = 15.62), stage III of necrotizing enterocolitis (P<0.001, OR = 47.5), to require surgical treatment (P<0.001, OR = 47.5), to have intestinal necrosis (P=0.001, OR = 48.5) or perforation (P=0.016, OR =24.25), to have medical complications, specifically intravascular disseminated coagulation (P<.001, RR = 98), and multi-organ failure (P<0.001, RR = 2). It was also found that patients with gastrointestinal symptoms and diagnosis of necrotising enterocolitis when they were hospitalized were more likely to have surgical treatment. CONCLUSIONS: We must be aware of the factors associated with mortality, as well as those associated with surgical treatment to reduce overall mortality for this condition.