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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Re-feeding gastric residuals | Active Comparator | 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. |
|
| Fresh feeding breastmilk/formula only | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Re-feeding residuals | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to establish full enteral feeding | Time required to reach enteral feeding at 120cc/kg/day | Birth to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel A Salas, MD | University of Alabama at Birmingham | Principal Investigator |
| Namasivayam Ambalavanan, MD | University of Alabama at Birmingham | Study Director |
| Waldemar A Carlo, MD | University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25552280 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Fresh Feeding Breastmilk or Formula only | Procedure | 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. |
|
Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of < 12 hours. |
| Birth to 28 days |
| Number of days receiving parenteral nutrition | Total number of days or partial day receiving parenteral nutrition | Birth to 28 days |
| Duration of hospital stay | Length of hospital stay in days | Birth to 120 days or discharge, whichever occurs first. |
| Diagnosis of necrotizing enterocolitis | Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV | 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. | Birth to 120 days or discharge, whichever occurs first |
| Death | Death prior to 121 days of age. | Birth to 120 days |
| D000091642 | Urogenital Diseases |