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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Time to establish full enteral feeding
Time required to reach enteral feeding at 120cc/kg/day
Time frame: Birth to 28 days
Feeding intolerance
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.
Time frame: 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.
Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of \< 12 hours.
Time frame: Birth to 28 days
Number of days receiving parenteral nutrition
Total number of days or partial day receiving parenteral nutrition
Time frame: Birth to 28 days
Duration of hospital stay
Length of hospital stay in days
Time frame: Birth to 120 days or discharge, whichever occurs first.
Diagnosis of necrotizing enterocolitis
Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV
Time frame: Birth to 120 days or discharge, whichever occurs first.
Diagnosis of intestinal perforation
Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.
Time frame: Birth to 120 days or discharge, whichever occurs first
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Death
Death prior to 121 days of age.
Time frame: Birth to 120 days