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

University of California San Francisco (UCSF)

Status: Withdrawn

Conditions: Hyperbilirubinemia, Neonatal

Treatments: Dietary Supplement: Nutramigen Infant Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT01330667

ELF for Hyperbilirubinemia

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 36 to 96 hours old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Formula Supplementation

Experimental group

Description:

Participants will supplement feedings with early limited formula following nursing.

Treatment:

Dietary Supplement: Nutramigen Infant Formula

Control

No Intervention group

Description:

Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.