Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
NCT ID: NCT01330667
Last Updated: 2018-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-07-31
2016-06-30
Brief Summary
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Detailed Description
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* 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
Outcome Measures
* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Formula Supplementation
Participants will supplement feedings with early limited formula following nursing.
Nutramigen Infant Formula
Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.
Control
Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.
No interventions assigned to this group
Interventions
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Nutramigen Infant Formula
Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Infants who have received or are receiving Level II or Level III
* Infants who have already lost ≥ 10% birth weight
* Infants with Glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising
36 Hours
96 Hours
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Valerie Flaherman, MD,MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco Medical Center
San Francisco, California, United States
Countries
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Other Identifiers
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ELF for Hyperbilirubinemia
Identifier Type: -
Identifier Source: org_study_id
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