Re-feeding Gastric Residuals in Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ariel Salas, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01420263
First received: August 17, 2011
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention
Premature; Infant, Light-for-dates
Procedure: Re-feeding residuals
Procedure: Fresh Feeding Breastmilk or Formula only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Time to establish full enteral feeding [ Time Frame: Birth to 28 days ] [ Designated as safety issue: No ]
    Time required to reach enteral feeding at 120cc/kg/day


Secondary Outcome Measures:
  • Feeding intolerance [ Time Frame: Birth to 28 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: Birth to 28 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Birth to 28 days ] [ Designated as safety issue: No ]
    Total number of days or partial day receiving parenteral nutrition

  • Duration of hospital stay [ Time Frame: Birth to 120 days or discharge, whichever occurs first. ] [ Designated as safety issue: No ]
    Length of hospital stay in days

  • Diagnosis of necrotizing enterocolitis [ Time Frame: Birth to 120 days or discharge, whichever occurs first. ] [ Designated as safety issue: Yes ]
    Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV

  • Diagnosis of intestinal perforation [ Time Frame: Birth to 120 days or discharge, whichever occurs first ] [ Designated as safety issue: Yes ]
    Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.

  • Death [ Time Frame: Birth to 120 days ] [ Designated as safety issue: Yes ]
    Death prior to 121 days of age.


Enrollment: 72
Study Start Date: August 2011
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420263

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Ariel Salas, MD, Fellow Instructor, Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01420263     History of Changes
Other Study ID Numbers: UAB Neo 004
Study First Received: August 17, 2011
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
premature infant
feeding
residuals
fresh feeds
full feeds
digestive system

ClinicalTrials.gov processed this record on September 14, 2014