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| Name | Class |
|---|---|
| Milton S. Hershey Medical Center | OTHER |
| HRSA/Maternal and Child Health Bureau | FED |
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This is a randomized, controlled trial designed to evaluate a new strategy for promoting continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed to each baby by syringe after each breastfeeding prior to the onset of mature milk production. The study intervention is discontinued at the onset of mature milk production, and the investigators will then follow mothers and infants for 12 months to assess the effect of ELF on breastfeeding duration, maternal experience and healthcare utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Limited Formula | Experimental | 10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production |
|
| Standard Care | Other | Continue exclusive breastfeeding unless otherwise instructed by a health care provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Limited Formula | Other | 10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of breastfeeding duration | The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| State Trait Anxiety Inventory | The investigators will follow mothers for 1 month to measure their responses on the State Trait Anxiety Inventory. | 1 month |
| Health care utilization | The investigators will follow babies for 1 month to determine how often they were seen by an outpatient provider, inpatient provider or emergency provider. |
| Measure | Description | Time Frame |
|---|---|---|
| Edinburg Postnatal Depression Scale | The investigators will follow mothers for 1 month to determine their score on the Edinburg Postnatal Depression Scale | 1 month |
| Breastfeeding Self-Efficacy Scale | The investigators will follow mothers for 1 month to determine their score on the Breastfeeding Self-Efficacy Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Flaherman, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco Medical Center | San Francisco | California | 94122 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31157878 | Derived | Flaherman VJ, Cabana MD, McCulloch CE, Paul IM. Effect of Early Limited Formula on Breastfeeding Duration in the First Year of Life: A Randomized Clinical Trial. JAMA Pediatr. 2019 Aug 1;173(8):729-735. doi: 10.1001/jamapediatrics.2019.1424. | |
| 29550235 | Derived | Flaherman VJ, Narayan NR, Hartigan-O'Connor D, Cabana MD, McCulloch CE, Paul IM. The Effect of Early Limited Formula on Breastfeeding, Readmission, and Intestinal Microbiota: A Randomized Clinical Trial. J Pediatr. 2018 May;196:84-90.e1. doi: 10.1016/j.jpeds.2017.12.073. Epub 2018 Mar 14. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard Care | Other | Continue exclusive breastfeeding unless otherwise directed by a health care provider |
|
| 1 month |
| Formula use | The investigators will follow babies for 6 months to determine the volume of formula used. | 6 months |
| 1 month |
| Satisfaction with Quality of Care | The investigators will follow mothers for 1 month to determine their score on the Satisfaction with Health Care Following Childbirth Scale | 1 month |
| Milk supply concern | The investigators will follow mothers for 1 month to determine their score on the Infant Satisfaction and Satiety Subscale | 1 month |
| Penn State Hershey Medical Center |
| Hershey |
| Pennsylvania |
| 17033 |
| United States |