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| Name | Class |
|---|---|
| Children's Miracle Network | OTHER |
| The Gerber Foundation | OTHER |
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This study is a randomized controlled trial seeking to determine whether supplementing infants at risk for excessive neonatal weight loss with a small volume of human donor milk prophylactically in the first 1-3 days of life, before maternal mature milk production (before mom's milk "comes in") will decrease the incidence of formula use at 1 week and 1, 2, and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk population.
We hypothesize that supplementation of term infants who have lost greater than or equal to 5% birth weight by 36 hours of age with a small volume of donor breast milk following feeds, until mature milk production, will result in decreased supplemental formula use at 1 week and increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive breastfeeding with offering early small-volume donor milk supplementation in a population of infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence of formula supplementation at 1 week of life and 2) improving breastfeeding duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusive breastfeeding | No Intervention | Infants in the exclusive breastfeeding group will continue to breastfeed. | |
| Donor Milk | Active Comparator | Infants in this arm will continue to breastfeed and will be given 10 ml of donor breast milk by syringe after each breastfeeding until their mother's milk "comes in." (until the onset of lactogenesis II) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donor Milk | Other | breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in." |
|
| Measure | Description | Time Frame |
|---|---|---|
| Any formula use at 1 week of age | Any formula intake within the last 24 hours. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Exclusive breastfeeding | Infants receiving breast milk and no formula in the last 24 hours. | 3 months |
| Any breastfeeding at 3 months | Infants receiving some breast milk in addition to some formula in the last 24 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura R Kair, MD | University of Iowa | Principal Investigator |
| Tarah T Colaizy, MD, MPH | University of Iowa | Study Director |
| Valerie J Flaherman, MD, MPH | University of California, San Francisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23669513 | Background | Flaherman VJ, Aby J, Burgos AE, Lee KA, Cabana MD, Newman TB. Effect of early limited formula on duration and exclusivity of breastfeeding in at-risk infants: an RCT. Pediatrics. 2013 Jun;131(6):1059-65. doi: 10.1542/peds.2012-2809. Epub 2013 May 13. | |
| 23864443 | Background | Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17. |
| Label | URL |
|---|---|
| Baby Friendly USA | View source |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| 3 months |
| Any breastfeeding | 1 month |
| Exclusive breastfeeding | 1 month |
| Exclusive breastfeeding | 2 months |
| Any breastfeeding | 2 months |
| Any breastfeeding | 1 week |
| 20113202 | Background | Flaherman VJ, Bokser S, Newman TB. First-day newborn weight loss predicts in-hospital weight nadir for breastfeeding infants. Breastfeed Med. 2010 Aug;5(4):165-8. doi: 10.1089/bfm.2009.0047. |
| 30688082 | Derived | Kair LR, Flaherman VJ, Colaizy TT. Effect of Donor Milk Supplementation on Breastfeeding Outcomes in Term Newborns: A Randomized Controlled Trial. Clin Pediatr (Phila). 2019 May;58(5):534-540. doi: 10.1177/0009922819826105. Epub 2019 Jan 28. |