Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
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|ClinicalTrials.gov Identifier: NCT01330667|
Recruitment Status : Unknown
Verified December 2014 by University of California, San Francisco.
Recruitment status was: Not yet recruiting
First Posted : April 7, 2011
Last Update Posted : December 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hyperbilirubinemia, Neonatal||Dietary Supplement: Nutramigen Infant Formula||Not Applicable|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||June 2016|
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.
- TSB meeting or exceeding AAP-recommended phototherapy treatment threshold. [ Time Frame: Up to two weeks after birth ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|