- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01420263
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
-
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Alabama
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Birmingham, Alabama, United States, 35249
- University of Alabama at Birmingham
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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:
- Gestational age between 23.0 and 28.6 weeks;
- Receiving intravenous fluids but not enteral nutrition more than trophic feeds;
- Written informed consent from the parents
Exclusion Criteria:
- Major congenital/chromosomal anomalies;
- 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.
|
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.
|
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
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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
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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.
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Birth to 28 days
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Number of days receiving parenteral nutrition
Time Frame: Birth to 28 days
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Total number of days or partial day receiving parenteral nutrition
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Birth to 28 days
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Duration of hospital stay
Time Frame: Birth to 120 days or discharge, whichever occurs first.
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Length of hospital stay in days
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Birth to 120 days or discharge, whichever occurs first.
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Diagnosis of necrotizing enterocolitis
Time Frame: Birth to 120 days or discharge, whichever occurs first.
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Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV
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Birth to 120 days or discharge, whichever occurs first.
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Diagnosis of intestinal perforation
Time Frame: Birth to 120 days or discharge, whichever occurs first
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Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.
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Birth to 120 days or discharge, whichever occurs first
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Death
Time Frame: Birth to 120 days
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Death prior to 121 days of age.
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Birth to 120 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
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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