Intestinal Disease Clinical Trial
Official title:
Enteral Administration of Lactated Ringer's Solution in Neonates With Feeding Intolerance, a Randomized Controlled Trial
The objective of this study is determining if enteral administration of Lactated Ringer's solution (LR) in preterm infants with feeding intolerance enables for faster advancement of milk feeding than fasting.
Feeding intolerance is a common problem in premature infants in the Neonatal Intensive Care
Unit. Definition is clinical and based on abdominal distension, abdominal tenderness,
emesis, change in gastric residuals, presence of blood in stool, and apnea with bradycardia.
Feeding intolerance is associated with serious complications: necrotizing enterocolitis,
longer hospitalization and prolonged intravenous nutrition complications (e.g. sepsis, liver
damage). Therefore, the investigators aim to achieve adequate enteral nutrition as soon as
possible.
Because LR is a an amniotic fluid-like solution, it may improve gastro-intestinal function
and avoid fasting, as well as its multiple problems (e.g. intestinal atrophy and decreased
intestinal motility). LR was chosen as the test solution because of experience documenting
its safe use in comparable groups: in newborn resuscitation parenterally, in amnioinfusion,
and in bowel irrigation. Moreover, LR is similar in electrolytes composition to the
experimental solution used in previous studies by Barney et al in neonates.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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