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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2016-09-12

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)

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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.

Conditions

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Feeding Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Fast milk advancement

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

Group Type EXPERIMENTAL

Fast milk advancement

Intervention Type OTHER

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

Traditional milk advancement

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

Group Type ACTIVE_COMPARATOR

Traditional milk advancement

Intervention Type OTHER

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

Interventions

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Fast milk advancement

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

Intervention Type OTHER

Traditional milk advancement

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

Intervention Type OTHER

Other Intervention Names

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Milk Milk

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

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No