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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD117932 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.
Participants will be randomized once they reach 120 mL/kg/day. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL/kg/day or 180-200 mL/kg/day. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: 180-200 mL/kg/day of human milk | Experimental | Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age. |
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| Control:140-160 mL/kg/day of human milk | Placebo Comparator | Study participants randomized to the control group will receive 140-160 mL/kg/day of human milk for 34 weeks corrected age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human milk | Dietary Supplement | maternal breastmilk or donor breastmilk |
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| Measure | Description | Time Frame |
|---|---|---|
| Fat-free Mass (FFM)-For-age-Z-score | Estimated by bioelectric impedance analysis. FFM measurements will be converted into Z-scores using updated, sex specific reference curves of body composition in preterm infants | 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat percentage | Estimated by bioelectric impedance analysis. Body fat measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants. | Birth to 36 weeks postmenstrual age |
| Anthropometric Measurements |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Intestinal Microbiome | Determined by molecular analyses of fecal samples | Birth to 36 weeks postmenstrual age |
| Changes in Metabolic Pathways | Determined by molecular analyses of serum samples |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariel A. Salas, MD, MSPH | Contact | 205-934-4680 | asalas@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ariel A. Salas, MD, MSPH | UAB Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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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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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Parallel Assignment
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Weight, length, head circumference, and mid-upper arm circumference measurements. Measurements will be converted into Z-scores based on Fenton growth curves (2013). |
| Birth to 36 weeks postmenstrual age |
| Bronchopulmonary Dysplasia | Number of participants receiving supplemental oxygen at 36 weeks (PMA) | 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer |
| Number of Days Alive and Receiving Full Enteral Feeding | Time to full enteral feeding days | Birth to 28 days |
| Duration of Hospital Stay in Days | From day of admission to day of hospital discharge to home | Birth to 120 days or discharge, whichever occurs first |
| Growth Rate | Weight gain in g/kg/day | Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first). |
| Number of Participants with Postnatal Faltering Growth | Diagnosis of faltering growth (weight z score decline from birth to 36 weeks > 1) using the 2013 Fenton growth curve. | 36 weeks or hospital discharge (whichever occurs first) |
| Number of Participants diagnosed with Necrotizing Enterocolitis | Diagnosis of necrotizing enterocolitis stage 2 or 3 | From birth up to 120 days following birth |
| Number of Participants with Diagnosis of Intestinal Perforation | Diagnosis of intestinal perforation | From birth up to 120 days following birth |
| Death | Death prior to 121 days of life | Birth to 120 days |
| Culture-proven Sepsis | Diagnosis of sepsis with positive blood cultures | Birth to 120 days |
| Fat Mass (FM)- For age Z-score | Estimated by bioelectric impedance analysis. FM measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants. | 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer |
| Body Fat (BF)-For age Z-score | Estimated by bioelectric impedance analysis. BF measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants. | 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer |
| Duration of parenteral nutrition | Number of days receiving parenteral nutrition | Birth to 28 days of life |
| Post discharge growth outcomes | Weight, length, and head circumference measurements. Measurements will be converted into Z-scores. | 22-26 months corrected age |
| 36 weeks postmenstrual age or discharge (whichever occurs first) |
| Cognitive scores | Neurodevelopmental outcomes measured by voluntary PARCA-R survey | 2 - 3 years of age |
| University of Mississippi Medical Center | Not yet recruiting | Jackson | Mississippi | 39216 | United States |
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| University of Texas Southwestern Medical Center at Dallas | Not yet recruiting | Dallas | Texas | 75235 | United States |
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| University of Texas Health Science Center at Houston | Not yet recruiting | Houston | Texas | 77030 | United States |
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| D000091642 | Urogenital Diseases |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |