Back to resultsEffects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS
Primary Purpose
Premature Infant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No gastric residual evaluation
Sponsored by
About this trial
This is an interventional treatment trial for Premature Infant focused on measuring Very low birth weight infants, premature, nutrition, gastric residual
Eligibility Criteria
Inclusion Criteria:
- Gestational age less than 32 weeks,
- Birth weight less than or equal to 1250 grams,
- Initial feeding tolerated within 48 hours of life
Exclusion Criteria:
- Congenital or chromosomal disorders,
- Severe complications leading to death in the first week of life
Sites / Locations
- UF & Shands Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
no gastric residual evaluation
gastric residual evaluation
Arm Description
Infants will not receive routine gastric residual evaluation prior to feeding
Infants will receive routine gastric residual evaluation
Outcomes
Primary Outcome Measures
Amount of feeding intake at 2 weeks
Secondary Outcome Measures
Days to 120 mL/kg/d of enteral feedings
Days of parenteral nutrition
Incidence of late onset sepsis
Weekly or biweekly liver function tests
Direct bilirubin
Growth indices
Weight, length and head circumference
Length of hospital stay
Incidence of necrotizing enterocolitis
Days requiring a central venous line
Full Information
NCT ID
NCT01965769
First Posted
October 15, 2013
Last Updated
October 15, 2013
Sponsor
University of Florida
Collaborators
The Gerber Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01965769
Brief Title
Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS
Official Title
Effects Of Not Measuring Gastric Residuals Prior To Enteral Bolus Feeding On Gastrointestinal Function And Feeding Tolerance In Very Low Birth Weight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
The Gerber Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.
Detailed Description
Infants were randomized into 2 groups. Group 1 had no gastric residuals evaluated prior to feeding. Group 2 had gastric residuals evaluated prior to feeding. Nutritional outcomes were compared between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant
Keywords
Very low birth weight infants, premature, nutrition, gastric residual
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no gastric residual evaluation
Arm Type
Experimental
Arm Description
Infants will not receive routine gastric residual evaluation prior to feeding
Arm Title
gastric residual evaluation
Arm Type
No Intervention
Arm Description
Infants will receive routine gastric residual evaluation
Intervention Type
Other
Intervention Name(s)
No gastric residual evaluation
Intervention Description
Infants will not receive routine gastric residual evaluation prior to feeding.
Primary Outcome Measure Information:
Title
Amount of feeding intake at 2 weeks
Time Frame
Baseline to 2 weeks
Secondary Outcome Measure Information:
Title
Days to 120 mL/kg/d of enteral feedings
Time Frame
Baseline to approximately 21 days
Title
Days of parenteral nutrition
Time Frame
Baseline to approximately 21 days
Title
Incidence of late onset sepsis
Time Frame
Baseline to approximately 90 days
Title
Weekly or biweekly liver function tests
Description
Direct bilirubin
Time Frame
Baseline to 42 days
Title
Growth indices
Description
Weight, length and head circumference
Time Frame
Baseline to approximately 90 days
Title
Length of hospital stay
Time Frame
Baseline to approximately 90 days
Title
Incidence of necrotizing enterocolitis
Time Frame
Baseline to approximately 90 days
Title
Days requiring a central venous line
Time Frame
Baseline to approximately 21 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age less than 32 weeks,
Birth weight less than or equal to 1250 grams,
Initial feeding tolerated within 48 hours of life
Exclusion Criteria:
Congenital or chromosomal disorders,
Severe complications leading to death in the first week of life
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Neu, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF & Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS
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