Re-feeding Gastric Residuals in Preterm Infants
Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants
1 other identifier
interventional
72
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
August 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFebruary 11, 2013
February 1, 2013
1.2 years
August 17, 2011
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to establish full enteral feeding
Time required to reach enteral feeding at 120cc/kg/day
Birth to 28 days
Secondary Outcomes (7)
Feeding intolerance
Birth to 28 days
Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.
Birth to 28 days
Number of days receiving parenteral nutrition
Birth to 28 days
Duration of hospital stay
Birth to 120 days or discharge, whichever occurs first.
Diagnosis of necrotizing enterocolitis
Birth to 120 days or discharge, whichever occurs first.
- +2 more secondary outcomes
Study Arms (2)
Re-feeding gastric residuals
ACTIVE COMPARATORIn 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.
Fresh feeding breastmilk/formula only
ACTIVE COMPARATORIn 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Major congenital/chromosomal anomalies;
- Moribund infant with low likelihood of survival, in the opinion of the clinical team
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Related Publications (1)
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.
PMID: 25552280DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow Instructor, Department of Pediatrics, Division of Neonatology
Study Record Dates
First Submitted
August 17, 2011
First Posted
August 19, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2012
Study Completion
January 1, 2013
Last Updated
February 11, 2013
Record last verified: 2013-02