Re-feeding Gastric Residuals in Preterm Infants

February 7, 2013 updated by: Ariel Salas, MD, University of Alabama at Birmingham

Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants

The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants. Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Primary outcome measure is time to establish full enteral feedings (120cc/kg/day).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Feeding advancement determined by clinical physicians.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

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

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Gestational age between 23.0 and 28.6 weeks;
  2. Receiving intravenous fluids but not enteral nutrition more than trophic feeds;
  3. Written informed consent from the parents

Exclusion Criteria:

  1. Major congenital/chromosomal anomalies;
  2. Moribund infant with low likelihood of survival, in the opinion of the clinical team

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Re-feeding gastric residuals
In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
Procedure: Re-feeding residuals
In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
Active Comparator: Fresh feeding breastmilk/formula only
In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breast milk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
Procedure: Fresh Feeding Breastmilk or Formula only
In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breastmilk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to establish full enteral feeding
Time Frame: Birth to 28 days
Time required to reach enteral feeding at 120cc/kg/day
Birth to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding intolerance
Time Frame: Birth to 28 days
Feeding intolerance defined as interruption or cessation of enteral feeds for a perod greater than 12 hours for presence of bloody gastric residuals or an abnormal abdominal examination.
Birth to 28 days
Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.
Time Frame: Birth to 28 days
Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of < 12 hours.
Birth to 28 days
Number of days receiving parenteral nutrition
Time Frame: Birth to 28 days
Total number of days or partial day receiving parenteral nutrition
Birth to 28 days
Duration of hospital stay
Time Frame: Birth to 120 days or discharge, whichever occurs first.
Length of hospital stay in days
Birth to 120 days or discharge, whichever occurs first.
Diagnosis of necrotizing enterocolitis
Time Frame: Birth to 120 days or discharge, whichever occurs first.
Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV
Birth to 120 days or discharge, whichever occurs first.
Diagnosis of intestinal perforation
Time Frame: Birth to 120 days or discharge, whichever occurs first
Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.
Birth to 120 days or discharge, whichever occurs first
Death
Time Frame: Birth to 120 days
Death prior to 121 days of age.
Birth to 120 days

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Ariel A Salas, MD, University of Alabama at Birmingham
  • Study Director: Namasivayam Ambalavanan, MD, University of Alabama at Birmingham
  • Study Chair: Waldemar A Carlo, MD, University of Alabama at Birmingham

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

August 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (Estimate)

August 19, 2011

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAB Neo 004

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.

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