Feeding Behavior Clinical Trial
Official title:
Effectiveness and Safety of Rapid Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight
This is a randomized controlled trial with infants less than 34 weeks and between 1000 and 2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)
Progression of enteral feeding in preterm infants is still controversial. The neonatologist
needs to provide adequate caloric intake avoiding the risk of food intolerance and
necrotizing enterocolitis.
Objective: To establish the safety and effectiveness of fast enteral advancement compared
with traditional advancement.
Design: A randomized controlled clinical trial with infants less than 34 weeks and between
1000 and 2000 grams at birth conducted at Hospital Universitario San Ignacio in Bogotá,
Colombia.
Methods: 30 cc versus 20 cc / kg / day advancing in infants between 1000 and 1499g and 40cc
versus 20 cc / kg / day advancing in infants between 1500 and 1999g.
Outcomes: days to reach full enteral nutrition, days of parenteral nutrition (PN) and/or
intravenous fluids (IVF), days to regain birth weight, episodes of food intolerance,
anthropometric measurements and weight gain at 40 weeks; rate of late onset sepsis,
hypoglycemia, hyperbilirubinemia, necrotizing enterocolitis (NEC) and mortality. Data will be
analyzed with Student t test or Mann-Whitney U-test and Pearson Chi-square or Fisher test.
Multiple linear regression will be performed.
Ethics: This Protocol was approved by the Ethics and Research Committee of Pontificia
Universidad Javeriana and San Ignacio Hospital. Informed consent will be requested to
parents.
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