Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS

October 15, 2013 updated by: University of Florida

Effects Of Not Measuring Gastric Residuals Prior To Enteral Bolus Feeding On Gastrointestinal Function And Feeding Tolerance In Very Low Birth Weight Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

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
    • Florida
      • Gainesville, Florida, United States, 32611
        • UF & Shands Hospital

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:

  • 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

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
Experimental: no gastric residual evaluation
Infants will not receive routine gastric residual evaluation prior to feeding
Other: No gastric residual evaluation
Infants will not receive routine gastric residual evaluation prior to feeding.
No Intervention: gastric residual evaluation
Infants will receive routine gastric residual evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of feeding intake at 2 weeks
Time Frame: Baseline to 2 weeks
Baseline to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days to 120 mL/kg/d of enteral feedings
Time Frame: Baseline to approximately 21 days
Baseline to approximately 21 days
Days of parenteral nutrition
Time Frame: Baseline to approximately 21 days
Baseline to approximately 21 days
Incidence of late onset sepsis
Time Frame: Baseline to approximately 90 days
Baseline to approximately 90 days
Weekly or biweekly liver function tests
Time Frame: Baseline to 42 days
Direct bilirubin
Baseline to 42 days
Growth indices
Time Frame: Baseline to approximately 90 days
Weight, length and head circumference
Baseline to approximately 90 days
Length of hospital stay
Time Frame: Baseline to approximately 90 days
Baseline to approximately 90 days
Incidence of necrotizing enterocolitis
Time Frame: Baseline to approximately 90 days
Baseline to approximately 90 days
Days requiring a central venous line
Time Frame: Baseline to approximately 21 days
Baseline to approximately 21 days

Collaborators and Investigators

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

Sponsor

University of Florida

Collaborators

The Gerber Foundation

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

March 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 15, 2013

First Posted (Estimate)

October 18, 2013

Study Record Updates

Last Update Posted (Estimate)

October 18, 2013

Last Update Submitted That Met QC Criteria

October 15, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-216
  • Gerber003 (Other Identifier: Gerber)

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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