Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5 K12 HD052 163 Development |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stanford University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). Both groups will receive intensive lactation support. Outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Limited Formula | Experimental | Participants will supplement feedings with early limited formula following nursing |
|
| Control | No Intervention | Participants are instructed to continue exclusively breastfeeding; no use of formula |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutramigen infant formula | Dietary Supplement | Investigators will advise mothers to supplement with 10 cc of elemental formula immediately following each breastfeeding and to discontinue formula once mature milk production begins. |
| Measure | Description | Time Frame |
|---|---|---|
| Is infant receiving exclusively breast milk at 8 days of life? | 8 days following baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months? | 1-3 months following baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 94143 | United States |
Not provided
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided