The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Oral formulation of insulin fed concomitantly with infant formula
Oral formulation of placebo fed concomitantly with infant formula
NICU, Laniado Hospital
Netanya, Israel
Number of days to achieve complete enteral feeding
Time frame: Up to 28 days or discharge and at 3 months of age
Number of gastric residual > 2 ml/kg
Time frame: Up to 28 days or discharge, at 3 months of age
Number of gastric residual > 50% of previous feeding
Time frame: Up to 28 days or discharge and at 3 months of age
Number of days to discharge
Time frame: Up to 28 days or discharge and at 3 months of age
Weight gain
Time frame: Up to 28 days or discharge and at 3 months of age
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