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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
2.5 ml per kg every 3 hours, via nasogastric tube, orogastric tube or orally, until the infant reaches 80 ml/kg/day of milk feeding or for a maximum of 14 days
McGill University Health Center
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Average of the daily enteral caloric intake (in calories/kg/day) received over the 14 days after study entry
To measure enteral caloric intake, the volume of milk feeding, for each patient will be recorded daily and for 14 days. Unfortified milk and fortified milk are calculated as containing respectively 0.67 Cal/ml and 0.81 Cal/ml.
Time frame: 14 days
Number of days to reach 130 ml/kg milk feeding
Time frame: variable
Number of days to discontinue IV access
Time frame: variable
Growth (weight, height, head circumference), increase % after 14 days and between study entry and discharge home
Time frame: variable
Length of hospitalization
Time frame: variable
Necrotizing enterocolitis
Time frame: during the 14 day-study period and hospitalization
Electrolytes, bilirubin, serum urea nitrogen, creatinine and liver enzymes
Time frame: 14 days
Infections
Time frame: until discharge
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