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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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

Sponsor: University of California, San Francisco

Current Primary Outcome: TSB meeting or exceeding AAP-recommended phototherapy treatment threshold. [ Time Frame: Up to two weeks after birth ]

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.


Original Primary Outcome: TSB meeting or exceeding AAP-recommended phototherapy treatment threshold. [ Time Frame: Up to two weeks ]

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


Current Secondary Outcome: Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy [ Time Frame: Up to three months after birth ]

The investigators will ask mothers whether the infant received any breast milk in the last 24 hours. For infants whose mothers state they have received breast milk in the last 24 hours, the investigators will ask mothers whether the infant received anything other than breast milk in the last 24 hours. The investigators will ask mothers whether the infant received anything other than breast milk since the prior assessment. The investigators will query subjects using the Breastfeeding Self Efficacy Scale, short form, at enrollment, 1week and at 1 month.


Original Secondary Outcome: Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy [ Time Frame: Up to three months ]

The investigators will ask mothers whether the infant received any breast milk in the last 24 hours. For infants whose mothers state they have received breast milk in the last 24 hours, the investigators will ask mothers whether the infant received anything other than breast milk in the last 24 hours. The investigators will ask mothers whether the infant received anything other than breast milk since the prior assessment. The investigators will query subjects using the Breastfeeding Self Efficacy Scale, short form, at enrollment, 1week and at 1 month.


Information By: University of California, San Francisco

Dates:
Date Received: February 23, 2011
Date Started: July 2015
Date Completion: June 2016
Last Updated: December 15, 2014
Last Verified: December 2014