Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-06 @ 8:21 AM
Study NCT ID:
NCT01330667
Status:
WITHDRAWN
Last Update Posted:
2018-11-15
First Post:
2011-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding not available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Inclusion criteria
* 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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: