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The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.
In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusively Human Milk Diet | Experimental | This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation. |
|
| Formula-based Diet | No Intervention | If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donor Breast Milk | Other | Donor breast milk will be given to the newborn if supplementation is required |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Feasibility_1 | Feasibility will be evaluated by: consent rate | 6-8 weeks chronological age |
| Study Feasibility_2 | Feasibility will be evaluated by: study completion rate | 6-8 weeks chronological age |
| Study Feasibility_3 | Feasibility will be evaluated by: rate of adherence to the study diet. | 6-8 weeks chronological age |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Human Milk Consumption at Discharge | Maternal milk/total milk (percent) consumed by the neonate over 48 hours | at the time of NICU discharge or 7 days of age, whichever is later |
| Percentage of Human Milk Consumption After Discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal Microbiome: microbial profiling (genus level) | Microbial profiling (genus level) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene | 7 days of age |
| Intestinal Microbiome: alpha diversity (Chao1) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara L Calkins, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90025 | United States | ||
| Santa Monica-UCLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17148007 | Background | Adamkin DH. Feeding problems in the late preterm infant. Clin Perinatol. 2006 Dec;33(4):831-7; abstract ix. doi: 10.1016/j.clp.2006.09.003. | |
| 19881390 | Background | Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0. |
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There is no current plan to make IPD available for other research given this is a small pilot feasibility study.
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Maternal milk/total milk (percent) consumed by the infant over 48 hours
| 6-8 weeks chronological age |
| Breastfeeding duration | time infant received breastmilk since birth | 6-8 weeks chronological age |
| Intent to Breastfeed | Mother's desire to continue to breastfeed: specifically assessed by asking the mother if she plans to exclusively breastfeed or not. Answers will be recorded as yes or no. | 6-8 weeks chronological age |
| Growth: Weight | Weight in kilograms reported as a z-score | 6-8 weeks chronological age |
| Growth: Height | height in centimeters reported as a z-score | 6-8 weeks chronological age |
| Growth: Head Circumference | head circumference in centimeters reported as a z-score | 6-8 weeks chronological age |
Alpha diversity (Chao1) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene
| 7 days of age |
| Los Angeles |
| California |
| 90404 |
| United States |
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