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. 2018 Jun 4;2018(6):CD008687. doi: 10.1002/14651858.CD008687.pub2

EudraCT 2007‐006102‐19.

Trial name or title Omeprazole treatment for prophylaxis of gastrointestinal bleeding and gastro‐oesophageal reflux in critically ill children [Tratamiento con omeprazole para la profilaxis de la hemorragia digestiva y el reflujo gastroesofágico en niños críticos]
Methods
Participants Infants and toddlers, children, adolescents, under 18
Interventions Intervention: 0.4 mL omeprazole IV
Control: 10 mL ranitidine IV
Outcomes Primary outcomes:
  • Gastric pH

  • Percentage of time with gastric pH > 4

  • Presence and intensity of gastric haemorrhage

  • Number and duration of gastric reflux

  • Bacterial count of gastric juice and tracheal aspirate

  • Incidence of nosocomial pneumonia

  • Heart rate, blood pressure, central venous pressure

  • Side effects


Secondary outcomes:
Starting date February 2008
Contact information
Notes clinicaltrialsregister.eu/ctr‐search/search?query=EUCTR2007‐006102‐19‐ES