Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia|
- TSB meeting or exceeding AAP-recommended phototherapy treatment threshold. [ Time Frame: Up to two weeks after birth ] [ Designated as safety issue: No ]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.
- Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy [ Time Frame: Up to three months after birth ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Formula Supplementation
Participants will supplement feedings with early limited formula following nursing.
Dietary Supplement: Nutramigen Infant Formula
Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.
Other Name: Nutramigen
No Intervention: Control
Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.
- Healthy infants ≥ 35 weeks
- Neonates 36-96 hours old
- Exclusively breastfeeding
- TSB 0.1-3 mg/dl below AAP-recommended PT threshold
- TSB < 6 hours ago
- Mothers English-speaking or Spanish-speaking
- Primary outcome: Total Serum Bilirubin
- Secondary clinical outcomes: Phototherapy, hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330667
|Contact: Helen Ashton||415-476-2859|
|United States, California|
|University of California, San Francisco Medical Center||Not yet recruiting|
|San Francisco, California, United States, 94122|
|Principal Investigator: Valerie Flaherman, MD,MPH|
|Principal Investigator:||Valerie Flaherman, MD,MPH||University of California, San Francisco|