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The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.
Inclusion criteria
Outcome Measures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formula Supplementation | Experimental | Participants will supplement feedings with early limited formula following nursing. |
|
| Control | No Intervention | Participants will be instructed to continue exclusively breastfeeding with no formula supplementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutramigen Infant Formula | Dietary Supplement | Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines. |
| Measure | Description | Time Frame |
|---|---|---|
| TSB meeting or exceeding AAP-recommended phototherapy treatment threshold. | The investigators will compare measured TSB to AAP guideline recommendations for phototherapy treatment and confirming with Bili Tool, an automated program designed for this purpose. | Up to two weeks after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy | The investigators will ask mothers whether the infant received any breast milk in the last 24 hours. For infants whose mothers state they have received breast milk in the last 24 hours, the investigators will ask mothers whether the infant received anything other than breast milk in the last 24 hours. The investigators will ask mothers whether the infant received anything other than breast milk since the prior assessment. The investigators will query subjects using the Breastfeeding Self Efficacy Scale, short form, at enrollment, 1week and at 1 month. |
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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 |
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D006932 | Hyperbilirubinemia |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C097269 | pregestimil |
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|
| Up to three months after birth |
| D005247 | Feeding Behavior |
| D001519 | Behavior |