Back to resultsRe-feeding Gastric Residuals in Preterm Infants
Primary Purpose
Premature; Infant, Light-for-dates
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Re-feeding residuals
Fresh Feeding Breastmilk or Formula only
Sponsored by
About this trial
This is an interventional treatment trial for Premature; Infant, Light-for-dates focused on measuring premature infant, feeding, residuals, fresh feeds, full feeds, digestive system
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Re-feeding gastric residuals
Fresh feeding breastmilk/formula only
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Time to establish full enteral feeding
Time required to reach enteral feeding at 120cc/kg/day
Secondary Outcome Measures
Feeding intolerance
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.
Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.
Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of < 12 hours.
Number of days receiving parenteral nutrition
Total number of days or partial day receiving parenteral nutrition
Duration of hospital stay
Length of hospital stay in days
Diagnosis of necrotizing enterocolitis
Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV
Diagnosis of intestinal perforation
Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.
Death
Death prior to 121 days of age.
Full Information
NCT ID
NCT01420263
First Posted
August 17, 2011
Last Updated
February 7, 2013
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT01420263
Brief Title
Re-feeding Gastric Residuals in Preterm Infants
Official Title
Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature; Infant, Light-for-dates
Keywords
premature infant, feeding, residuals, fresh feeds, full feeds, digestive system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Re-feeding gastric residuals
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fresh feeding breastmilk/formula only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Re-feeding residuals
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fresh Feeding Breastmilk or Formula only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to establish full enteral feeding
Description
Time required to reach enteral feeding at 120cc/kg/day
Time Frame
Birth to 28 days
Secondary Outcome Measure Information:
Title
Feeding intolerance
Description
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.
Time Frame
Birth to 28 days
Title
Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.
Description
Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of < 12 hours.
Time Frame
Birth to 28 days
Title
Number of days receiving parenteral nutrition
Description
Total number of days or partial day receiving parenteral nutrition
Time Frame
Birth to 28 days
Title
Duration of hospital stay
Description
Length of hospital stay in days
Time Frame
Birth to 120 days or discharge, whichever occurs first.
Title
Diagnosis of necrotizing enterocolitis
Description
Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV
Time Frame
Birth to 120 days or discharge, whichever occurs first.
Title
Diagnosis of intestinal perforation
Description
Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.
Time Frame
Birth to 120 days or discharge, whichever occurs first
Title
Death
Description
Death prior to 121 days of age.
Time Frame
Birth to 120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel A Salas, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Namasivayam Ambalavanan, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Waldemar A Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25552280
Citation
Salas AA, Cuna A, Bhat R, McGwin G Jr, Carlo WA, Ambalavanan N. A randomised trial of re-feeding gastric residuals in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F224-8. doi: 10.1136/archdischild-2014-307067. Epub 2014 Dec 31.
Results Reference
derived
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Re-feeding Gastric Residuals in Preterm Infants
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