Effectiveness and Safety of Rapid Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Feeding Behavior
- Sponsor
- Hospital Universitario San Ignacio
- Enrollment
- 36
- Primary Endpoint
- days of intravenous fluids
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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)
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants less than 34 weeks of gestational age.
- •Weight at birth between 1000 and 2000 grams.
- •Infants hospitalized in the newborn unit at Hospital Universitario San Ignacio in Bogotá, Colombia.
Exclusion Criteria
- •Perinatal Asphyxia
- •Intrauterine Growth Restriction
- •Diagnosis of Congenital Hearth Disease
- •Severe Hypoxemia
- •Major Congenital Malformations
- •Metabolic Disease
- •Intolerance to initiate oral feeding at the eligibility
- •Patent Ductus with hemodynamic instability
- •Early Onset Sepsis with hemodynamic instability
- •Refusal of parents to participate in the study
Outcomes
Primary Outcomes
days of intravenous fluids
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
number of days with intravenous fluids included parenteral nutrition and dextrose with electrolytes
days to reach full enteral nutrition
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
number of days employed to reach full enteral nutrition with breast milk, formula milk or breast milk plus formula milk.
Secondary Outcomes
- episodes of food intolerance(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 at 40 weeks of post menstrual age)
- rate of hyperbilirubinemia(from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks)
- rate of hypoglycemia(from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks)
- length at 40 weeks(length at 40 weeks of post menstrual age)
- head circumference at 40 weeks(head circumference at 40 weeks of post menstrual age)
- rate of necrotizing enterocolitis(through study completion(from date of randomization until 40 weeks of post menstrual age))
- rate of mortality(through study completion(from date of randomization until 40 weeks of post menstrual age))
- rate of late onset sepsis(from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks)
- days to regain birth weight(number of days from birth, employed to regain birth weight or date of death from any cause assessed up to 12 weeks)
- weight gain per day at 40 weeks of post menstrual age(weight gain in grams per day from birth until 40 weeks of post menstrual age)