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

Hospital Universitario San Ignacio

Status: Completed

Conditions: Feeding Behavior

Treatments: Other: Traditional milk advancement; Other: Fast milk advancement

Study type: Interventional

Funder types: Other

Identifiers

NCT02998489

2014/25

Details and patient eligibility

About

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)

Full 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.

Enrollment: 36 patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Fast milk advancement

Experimental group

Description:

30-40 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction

Treatment:

Other: Fast milk advancement

Traditional milk advancement

Active Comparator group

Description:

20 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction

Treatment:

Other: Traditional milk advancement