Trial | NCT02998489  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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 Started
Apr 01
2014
Primary Completion
Dec 31
2015
Study Completion
Sep 12
2016
Last Update
Mar 23
2018

Other Fast milk advancement

30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved

  • Other names: Milk

Other Traditional milk advancement

20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved

  • Other names: Milk

Fast milk advancement Experimental

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

Traditional milk advancement Active Comparator

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

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
No Results Posted