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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved
20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved
days to reach full enteral nutrition
number of days employed to reach full enteral nutrition with breast milk, formula milk or breast milk plus formula milk.
Time frame: number of days from date of randomization until the day that the baby reach full enteral nutrition or date of death from any cause assessed up to 12 weeks
days of intravenous fluids
number of days with intravenous fluids included parenteral nutrition and dextrose with electrolytes
Time frame: number of days of intravenous fluids from birth until suspension of them or date of death from any cause assessed up to 12 weeks
days to regain birth weight
number of days employed to regain birth weight
Time frame: number of days from birth, employed to regain birth weight or date of death from any cause assessed up to 12 weeks
episodes of food intolerance
number of episodes of food intolerance per day during hospitalization
Time frame: number of episodes of food intolerance per day from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
weight at 40 weeks
weight in grams at 40 weeks of post menstrual age
Time frame: weight at 40 weeks of post menstrual age
length at 40 weeks
length in centimeters at 40 weeks of post menstrual age
Time frame: length at 40 weeks of post menstrual age
head circumference at 40 weeks
head circumference in centimeters at 40 weeks of post menstrual age
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Time frame: head circumference at 40 weeks of post menstrual age
weight gain per day at 40 weeks of post menstrual age
weight gain in gr./d from birth until 40 weeks of post menstrual age
Time frame: weight gain in grams per day from birth until 40 weeks of post menstrual age
rate of necrotizing enterocolitis
rate of necrotizing enterocolitis through study completion
Time frame: through study completion(from date of randomization until 40 weeks of post menstrual age)
rate of mortality
number of patients who died during the study's follow up
Time frame: through study completion(from date of randomization until 40 weeks of post menstrual age)
rate of late onset sepsis
number of patients who had late onset sepsis during hospitalization
Time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
rate of hyperbilirubinemia
number of patients who had hyperbilirubinemia and were treated with phototherapy during hospitalization
Time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
rate of hypoglycemia
number of patients who had hypoglycemia during hospitalization
Time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks