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

This study is not yet open for participant recruitment.
Verified June 2012 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01330667
First received: February 23, 2011
Last updated: June 18, 2012
Last verified: June 2012
History of Changes

February 23, 2011
June 18, 2012
December 2012
December 2013   (final data collection date for primary outcome measure)
TSB meeting or exceeding AAP-recommended phototherapy treatment threshold. [ Time Frame: Up to two weeks after birth ] [ Designated as safety issue: No ]
The investigators will compare measured TSB to AAP guideline recommendations for phototherapy treatment and confirming with BiliTool, an automated program designed for this purpose.
TSB meeting or exceeding AAP-recommended phototherapy treatment threshold. [ Time Frame: Up to two weeks ] [ Designated as safety issue: No ]
The investigators will compare measured TSB to AAP guideline recommendations for phototherapy treatment and confirming with BiliTool, an automated program designed for this purpose.
Complete list of historical versions of study NCT01330667 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia

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.

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Hyperbilirubinemia, Neonatal
Dietary Supplement: Nutramigen Infant Formula
Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.
Other Name: Nutramigen
  • Experimental: Formula Supplementation
    Participants will supplement feedings with early limited formula following nursing.
    Intervention: Dietary Supplement: Nutramigen Infant Formula
  • No Intervention: Control
    Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
June 2014
December 2013   (final data collection date for primary outcome measure)

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 G6PD deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising
Both
up to 96 Hours
Yes
Contact: Helen Ashton 415-476-2859
United States
 
NCT01330667
ELF for Hyperbilirubinemia
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Valerie Flaherman, MD,MPH University of California, San Francisco
University of California, San Francisco
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP