Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
Primary Purpose
Hyperbilirubinemia, Neonatal
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutramigen Infant Formula
Sponsored by
About this trial
This is an interventional prevention trial for Hyperbilirubinemia, Neonatal focused on measuring Hyperbilirubinemia, Breastfeeding, Limited Formula
Eligibility Criteria
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
Sites / Locations
- University of California, San Francisco Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Formula Supplementation
Control
Arm Description
Participants will supplement feedings with early limited formula following nursing.
Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
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.
Full Information
NCT ID
NCT01330667
First Posted
February 23, 2011
Last Updated
November 13, 2018
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01330667
Brief Title
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
Official Title
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
funding not available
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbilirubinemia, Neonatal
Keywords
Hyperbilirubinemia, Breastfeeding, Limited Formula
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Formula Supplementation
Arm Type
Experimental
Arm Description
Participants will supplement feedings with early limited formula following nursing.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutramigen Infant Formula
Other Intervention Name(s)
Nutramigen
Intervention Description
Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.
Primary Outcome Measure Information:
Title
TSB meeting or exceeding AAP-recommended phototherapy treatment threshold.
Description
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.
Time Frame
Up to two weeks after birth
Secondary Outcome Measure Information:
Title
Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
Description
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.
Time Frame
Up to three months after birth
10. Eligibility
Sex
All
Minimum Age & Unit of Time
36 Hours
Maximum Age & Unit of Time
96 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Flaherman, MD,MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94122
Country
United States
12. IPD Sharing Statement
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Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
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