Clinical Trials Directory

Trials / Completed

CompletedNCT01420263

Re-feeding Gastric Residuals in Preterm Infants

Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
1 Day – 7 Days
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURERe-feeding residualsIn 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.
PROCEDUREFresh Feeding Breastmilk or Formula onlyIn 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.

Timeline

Start date
2011-08-01
Primary completion
2012-10-01
Completion
2013-01-01
First posted
2011-08-19
Last updated
2013-02-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01420263. Inclusion in this directory is not an endorsement.