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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
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To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.
Qualifying participants will be randomly assigned to one of two study groups: 1) Early progressive feeding without MEF or 2) Progressive feedings preceded by 4 days of MEF. Regardless of study group assignment, donor human milk will be offered if not enough of the mother's expressed breastmilk during the intervention phase of the trial.
Intervention group: Progressive feeding of 20-24 ml/kg/d on day 1 of feeding, followed by daily increments of 24-25 ml/kg/d as tolerated until full enteral feeding achieved.
Control group: MEF with feeding volumes of 20-24 ml/kg/d for 4 days followed by progressive feeding (daily increments of 24-25 ml/kg/d) as tolerated until full enteral feeding achieved.
Both groups will receive fast progressive feeding (>/= 24 ml/kg/day)
If parent agrees, stool "dirty" diapers will be collected 5 times (at birth, 1, 2, 3 and 4 weeks of life).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive Feeding without MEF | Experimental | This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved. |
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| Progressive Feeding with MEF | Active Comparator | This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Feeding without MEF | Other | This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days alive and receiving full enteral feeding | number of days alive on full enteral feeding in the first 28 days after birth | birth to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with diagnosis of necrotizing enterocolitis | diagnosis of necrotizing enterocolitis stage 2 or 3 | birth to 120 days or discharge, whichever occurs first |
| Number of participants with diagnosis of intestinal perforation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel A. Salas, MD, MSPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29529231 | Result | Salas AA, Li P, Parks K, Lal CV, Martin CR, Carlo WA. Early progressive feeding in extremely preterm infants: a randomized trial. Am J Clin Nutr. 2018 Mar 1;107(3):365-370. doi: 10.1093/ajcn/nqy012. | |
| 34775476 | Result | Salas AA, Willis KA, Carlo WA, Yi N, Zhang L, Van Der Pol WJ, Younge NE, Lefkowitz EJ, Lal CV. The gut microbiome of extremely preterm infants randomized to the early progression of enteral feeding. Pediatr Res. 2022 Sep;92(3):799-804. doi: 10.1038/s41390-021-01831-w. Epub 2021 Nov 13. |
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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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| Progressive Feeding with MEF | Other | This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved. |
|
| birth to 14 days |
| Death | death prior to 121 days of birth | birth to 120 days |
| Number of days alive and receiving full enteral feeding according to time of exposure to human milk and formula feeding the first 28 days | birth to 28 days |
| Time to establish full enteral feeding | time interval between birth and full enteral feeding at 120cc/kg/day | birth to 28 days |
| Number of episodes of feeding intolerance | interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination | birth to 28 days |
| Number of episodes of feeding intolerance resulting in an interruption or cessation of progressive enteral feeding for a period < 12 hours | birth to 28 days |
| Number of days receiving parenteral nutrition | birth to 28 days |
| Number of days requiring central line access | birth to 28 days |
| Number of episodes of culture proven sepsis | birth to 120 days or discharge, whichever occurs first |
| Growth/length at time of discharge | birth to 120 days or discharge, whichever occurs first |
| Duration of hospital stay in days | birth to 120 days or discharge, whichever occurs first |
| Changes in intestinal microbiome | Determined by molecular analyses of bacteria in fecal samples | birth to 28 days |
| 36442467 | Result | Durham L, Gunawan E, Nguyen K, Reeves A, Shukla V, Salas AA. Total Fluid Administration and Weight Loss during the First 2 Weeks in Infants Randomized to Early Enteral Feeding after Extremely Preterm Birth. Neonatology. 2023;120(2):257-262. doi: 10.1159/000527430. Epub 2022 Nov 28. |
| D000091642 | Urogenital Diseases |