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

NCT01330667 | Withdrawn

• 1 other identifier: ELF for Hyperbilirubinemia
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia, Neonatal

Keywords

Hyperbilirubinemia; Breastfeeding; Limited Formula

Outcome Measures

Primary Outcomes (1)

• TSB meeting or exceeding AAP-recommended phototherapy treatment threshold.

  The investigators will compare measured TSB to AAP guideline recommendations for phototherapy treatment and confirming with Bili Tool, an automated program designed for this purpose.

  Up to two weeks after birth

Secondary Outcomes (1)

• Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy

  Up to three months after birth

Study Arms (2)

Formula Supplementation

EXPERIMENTAL

Participants will supplement feedings with early limited formula following nursing.

Dietary Supplement: Nutramigen Infant Formula

Control

NO INTERVENTION

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

Interventions

Nutramigen Infant Formula DIETARY_SUPPLEMENT

Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.

Also known as: Nutramigen

Formula Supplementation

Eligibility Criteria

• Age: 36 Hours - 96 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco Medical Center

San Francisco, California, 94122, United States

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia; Breast Feeding

Interventions

pregestimil

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Valerie Flaherman, MD,MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: April 7, 2011
• Study Start: July 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: June 1, 2016
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

US (1)