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To test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged use of parenteral nutrition.
Qualifying participants will be randomly assigned to one of two study groups: 1) Exclusive Enteral Feeds or 2) Progressive Enteral Feeds with supplemental parenteral nutrition. Regardless of study group assignment, donor human milk will be offered if the mother's expressed breast milk is not enough to complete the intervention as assigned.
Intervention group: Feeds will be initiated with a target volume of 60-80 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150ml/kg/day is achieved.
Control group: Enteral feeds will be initiated with a target volume of 20-30 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150 ml/kg/day is achieved.
If parent agrees, stool "dirty" diapers will be collected 2 times during this study.
One time around the time of birth and one time at 28 days or discharge (whichever occurs first).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusive Enteral Nutrition | Experimental | This group will receive enteral feeding volumes at a rate of 60-80 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day. |
|
| Progressive Enteral Nutrition | Active Comparator | This group will receive enteral feeding volumes at a rate of 20-30 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exclusive Enteral Nutrition | Procedure | Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth | Days of full feeds in the first 28 days after birth | Birth to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to establish full enteral feeding | Time interval between birth and full enteral feeding at 150ml/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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal microbiome profile | Determined by molecular analyses of bacterial fragments in fecal samples | At postnatal day 14 |
| Fat-free mass z score | Determined by air-displacement plethysmography |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Shukla, MD | University of Alabama at Birmingham | Study Chair |
| Ariel Salas, MD, MSPH | University of Alabama at Birmingham | Study Director |
| Jacqueline Razzaghy, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41034647 | Result | Salas AA, Stewart CJ, Young GR. Early gut microbiome composition of very preterm infants randomised to receive human milk volumes of 60 ml/kg/day or more within the first 36 hours after birth. Pediatr Res. 2026 Jun;99(5):1964-1969. doi: 10.1038/s41390-025-04456-5. Epub 2025 Oct 2. | |
| 38135494 | Result | Razzaghy J, Shukla VV, Gunawan E, Reeves A, Nguyen K, Salas AA. Early and exclusive enteral nutrition in infants born very preterm. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):378-383. doi: 10.1136/archdischild-2023-325969. |
| Label | URL |
|---|---|
| Commentary | View source |
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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 Enteral Nutrition | Procedure | Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours. |
|
| Birth to 28 days |
| Number of days receiving parenteral nutrition and IV fluids | Birth to 28 days |
| Number of days receiving central line access | Birth to 28 days |
| Number of episodes of culture proven sepsis | Positive blood cultures | Birth to 60 days or discharge, whichever occurs first |
| Number of participants with diagnosis of necrotizing enterocolitis | Diagnosis of necrotizing enterocolitis stage 2 or 3 | Birth to 60 days or discharge, whichever occurs first |
| Number of participants with diagnosis of intestinal perforation | Pneumoperitoneum on abdominal radiograph | Birth to 14 days |
| Death | Birth to 60 days |
| Weight | Weekly measurements of weight in g | Birth to 60 days |
| Length | Weekly measurements of length in cm | Birth to 60 days |
| Head circumference | Weekly measurements of head circumference in cm | Birth to 60 days |
| Duration of hospital stay in days | Birth to 60 days |
| At postnatal day 14 |
| D000091642 | Urogenital Diseases |