Premature; Infant, Light-for-dates
Conditions
Keywords
premature infant, feeding, residuals, fresh feeds, full feeds, digestive system
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).
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.
Interventions
PROCEDURERe-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.
PROCEDUREFresh 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to establish full enteral feeding | Birth to 28 days | Time required to reach enteral feeding at 120cc/kg/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | Birth to 28 days | Total number of days or partial day receiving parenteral nutrition |
| Duration of hospital stay | Birth to 120 days or discharge, whichever occurs first. | Length of hospital stay in days |
| Feeding intolerance | Birth to 28 days | 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. |
| Diagnosis of intestinal perforation | Birth to 120 days or discharge, whichever occurs first | Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first. |
| Death | Birth to 120 days | Death prior to 121 days of age. |
| Diagnosis of necrotizing enterocolitis | Birth to 120 days or discharge, whichever occurs first. | Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV |
Countries
United States
Outcome results
None listed