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

Withdrawn before enrolling · Not applicable

Conditions studied: Hyperbilirubinemia, Neonatal

In brief

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.

Key facts

Study ID

NCT01330667

Run by

University of California, San Francisco

People needed

0

Starts

2015-07-01

Expected to finish

2016-06-01

Last updated by the study team

2018-11-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Infants who have already received formula
• 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

Where it is running

• University of California, San Francisco Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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