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1.
N Engl J Med ; 380(21): 2031-2040, 2019 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-31116919

RESUMO

BACKGROUND: Nasal high-flow therapy is an alternative to nasal continuous positive airway pressure (CPAP) as a means of respiratory support for newborn infants. The efficacy of high-flow therapy in nontertiary special care nurseries is unknown. METHODS: We performed a multicenter, randomized, noninferiority trial involving newborn infants (<24 hours of age; gestational age, ≥31 weeks) in special care nurseries in Australia. Newborn infants with respiratory distress and a birth weight of at least 1200 g were assigned to treatment with either high-flow therapy or CPAP. The primary outcome was treatment failure within 72 hours after randomization. Infants in whom high-flow therapy failed could receive CPAP. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome, with a noninferiority margin of 10 percentage points. RESULTS: A total of 754 infants (mean gestational age, 36.9 weeks, and mean birth weight, 2909 g) were included in the primary intention-to-treat analysis. Treatment failure occurred in 78 of 381 infants (20.5%) in the high-flow group and in 38 of 373 infants (10.2%) in the CPAP group (risk difference, 10.3 percentage points; 95% confidence interval [CI], 5.2 to 15.4). In a secondary per-protocol analysis, treatment failure occurred in 49 of 339 infants (14.5%) in the high-flow group and in 27 of 338 infants (8.0%) in the CPAP group (risk difference, 6.5 percentage points; 95% CI, 1.7 to 11.2). The incidences of mechanical ventilation, transfer to a tertiary neonatal intensive care unit, and adverse events did not differ significantly between the groups. CONCLUSIONS: Nasal high-flow therapy was not shown to be noninferior to CPAP and resulted in a significantly higher incidence of treatment failure than CPAP when used in nontertiary special care nurseries as early respiratory support for newborn infants with respiratory distress. (Funded by the Australian National Health and Medical Research Council and Monash University; HUNTER Australian and New Zealand Clinical Trials Registry number, ACTRN12614001203640.).


Assuntos
Pressão Positiva Contínua nas Vias Aéreas , Ventilação não Invasiva , Oxigenoterapia/métodos , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , Pressão Positiva Contínua nas Vias Aéreas/efeitos adversos , Feminino , Humanos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Masculino , Ventilação não Invasiva/efeitos adversos , Falha de Tratamento
2.
J Paediatr Child Health ; 48(6): 512-6, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22107074

RESUMO

AIM: Universal vaccination with an oral live-attenuated rotavirus vaccine at 2, 4 and 6 months of age was introduced in Australia in July 2007. There are no data on the short-term effects of vaccination for those infants most at risk of severe complications from rotavirus infection. The aim of this study was to describe the effects of rotavirus vaccination on weight gain and gastrointestinal losses in infants with functional short gut syndrome secondary to an ileostomy. METHODS: A retrospective review of all infants with an ileostomy who received RotaTeq while hospitalised at the Royal Children's Hospital, Melbourne from July 2007 to July 2009 was performed. Daily data were collected from 1 week before to 2 weeks after vaccination. The data included type and volume of feeds, ileostomy losses, need for fluid replacement of ileostomy losses, weight, temperature, urine sodium, stool culture, suspected and confirmed sepsis. RESULTS: Nine infants (age at first RotaTeq 61-99 days) were identified. The median (range) gestational age was 26 (24, 38) completed weeks and birthweight was 737 (620, 2714) grams. Compared to the day of vaccination, the median (range) ileostomy losses 1 week before, 1 and 2 weeks after vaccination were -1.1 (-13.6, 4.9) mL/kg/day, 2 (-11.1, 25.0) mL/kg/day and 2.4 (-15.7, 27.2) mL/kg/day, respectively. One infant developed severe stomal losses after vaccination. Overall, rotavirus vaccination did not alter weight gain, temperature or urinary sodium. CONCLUSION: In this small series, oral live-attenuated rotavirus vaccination of infants with high-output ileostomy was tolerated in most cases.


Assuntos
Ileostomia , Vacinação em Massa , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus , Síndrome do Intestino Curto/complicações , Administração Oral , Diarreia/etiologia , Humanos , Lactente , Recém-Nascido , Estudos Retrospectivos , Infecções por Rotavirus/complicações , Vacinas contra Rotavirus/administração & dosagem , Vacinas contra Rotavirus/efeitos adversos , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/efeitos adversos , Vitória , Aumento de Peso
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