NCT01330667

Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 36 Hours – 96 Hours
• Healthy volunteers: Accepted

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

Conditions

• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutramigen Infant Formula	Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-07-01
• Completion: 2016-06-01
• First posted: 2011-04-07
• Last updated: 2018-11-15

Locations

1 site across 1 country: United States