Effectiveness and Safety of Fast Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Safety of Rapid Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight

Conditions
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Feeding Behavior

Intervention / Treatment
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* Other: Fast milk advancement
* Other: Traditional milk advancement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast milk advancement<br>30-40 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction | Other: Fast milk advancement<br>* 30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved<br>* Other names: Milk;|
| Active Comparator: Traditional milk advancement<br>20 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction | Other: Traditional milk advancement<br>* 20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved<br>* Other names: Milk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | number of days of intravenous fluids from birth until suspension of them or date of death from any cause assessed up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days to regain birth weight | number of days employed 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 | 
| episodes of food intolerance | number of episodes of food intolerance per day during hospitalization | 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 | weight at 40 weeks of post menstrual age | 
| length at 40 weeks | length in centimeters at 40 weeks of post menstrual age | length at 40 weeks of post menstrual age | 
| head circumference at 40 weeks | head circumference in centimeters at 40 weeks of post menstrual age | 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 | 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 | 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 | 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 | 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 | 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 | from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enteral nutrition, infant,premature, feeding method