RESUMO
OBJECTIVE: To assess the safety and prebiotic effects of lactulose in preterm infants. STUDY DESIGN: This was a prospective, double-blinded, placebo-controlled, single-center study in 23- to 34-weeks premature infants. The study group received 1% lactulose, and control infants received 1% dextrose in all feeds (human milk or formula). RESULTS: Twenty-eight infants participated (15 lactulose, 13 placebo). Small doses of lactulose appeared to be safe and did not cause diarrhea. Premature infants on lactulose had more Lactobacilli-positive stool cultures that appeared earlier with larger number of colonies. The lactulose group tended to have less intolerance to enteral feedings, to reach full oral feeds earlier, and to be discharged home earlier. They also tended to have fewer episodes of late-onset sepsis, lower Bell stage necrotizing enterocolitis, and their nutritional laboratory indices were better, especially calcium and total protein. CONCLUSIONS: This pilot study supports the safety of supplementing preterm infants' feeds with low doses of lactulose. It also demonstrated trends that may suggest positive prebiotic effects.
Assuntos
Nutrição Enteral , Fármacos Gastrointestinais/uso terapêutico , Recém-Nascido Prematuro , Lactulose/uso terapêutico , Prebióticos , Contagem de Colônia Microbiana , Método Duplo-Cego , Feminino , Fármacos Gastrointestinais/administração & dosagem , Humanos , Recém-Nascido , Lactobacillus/crescimento & desenvolvimento , Lactulose/administração & dosagem , Masculino , Projetos Piloto , Prebióticos/efeitos adversos , Estudos Prospectivos , SegurançaRESUMO
OBJECTIVE: To evaluate the short and long-term clinical effects and the treatment-feasibility of inhaled-furosemide (IF) as compared with placebo via hood in hospitalized infants with viral-bronchiolitis (VB). STUDY-DESIGN: A randomized, double-blind, placebo-controlled pilot-study was performed in previously healthy infants (0-12 months). Enrolled infants were randomized to receive either IF (2 mg/kg), or placebo nebulized by hood three times daily throughout the hospitalization. Clinical assessment (respiratory distress assessment instrument [RDAI]) was performed before, 30 and 60 min after the 1st daily inhalation. The short-term effects were evaluated by the RDAI, respiratory assessment change score (RACS) and oxygen requirement and the long-term effects by time to be weaned off oxygen, time to full enteral feeding, length of stay, and "ready to discharge" time. RESULTS: Both groups (16 infants each) had comparable characteristics at study entry. Mean (+/-SD) age was 72 +/- 43 days, and 29/32 infants were RSV positive. Oxygen requirement (FiO(2)) decreased significantly at 30 min post-inhalation (30 +/- 9.2% to 26 +/- 7.1%, P < 0.05) only in the IF group. RACSs and long-term effects of both groups were comparable. Analysis of IF particles generated by the hood-nebulizer demonstrated that 36% and 49% of the particles were <3 and 5 microm, respectively. No side effects were observed during IF treatment. CONCLUSION: Based on our pilot study, IF has no significant clinical effects in hospitalized infants with VB. IF via hood seems to be feasible and safe.