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

March 22, 2018 updated by: Hospital Universitario San Ignacio

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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
Time Frame: number of days from birth, employed to regain birth weight or date of death from any cause assessed up to 12 weeks
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
Time Frame: 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
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
Time Frame: weight at 40 weeks of post menstrual age
weight in grams at 40 weeks of post menstrual age
weight at 40 weeks of post menstrual age
length at 40 weeks
Time Frame: length at 40 weeks of post menstrual age
length in centimeters at 40 weeks of post menstrual age
length at 40 weeks of post menstrual age
head circumference at 40 weeks
Time Frame: head circumference at 40 weeks of post menstrual age
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
Time Frame: weight gain in grams per day from birth until 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
Time Frame: through study completion(from date of randomization until 40 weeks of post menstrual age)
rate of necrotizing enterocolitis through study completion
through study completion(from date of randomization until 40 weeks of post menstrual age)
rate of mortality
Time Frame: through study completion(from date of randomization until 40 weeks of post menstrual age)
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
Time Frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
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
Time Frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
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
Time Frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario San Ignacio

Investigators

  • Principal Investigator: Adriana Montealegre, Dr., Hospital Universitario San Ignacio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

September 12, 2016

Study Registration Dates

First Submitted

December 11, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Feeding Behavior

Clinical Trials on Fast milk advancement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe