Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
This study is not yet open for participant recruitment.
Verified May 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01330667
First received: February 23, 2011
Last updated: May 21, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hyperbilirubinemia, Neonatal |
Dietary Supplement: Nutramigen Infant Formula |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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 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 [ 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.
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Formula Supplementation
Participants will supplement feedings with early limited formula following nursing.
|
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
|
|
No Intervention: Control
Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.
|
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
Eligibility| Ages Eligible for Study: | up to 96 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330667
Contacts
| Contact: Helen Ashton | 415-476-2859 |
Locations
| United States, California | |
| University of California, San Francisco Medical Center | Not yet recruiting |
| San Francisco, California, United States, 94122 | |
| Principal Investigator: Valerie Flaherman, MD,MPH | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Valerie Flaherman, MD,MPH | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01330667 History of Changes |
| Other Study ID Numbers: | ELF for Hyperbilirubinemia |
| Study First Received: | February 23, 2011 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Hyperbilirubinemia Breastfeeding Limited Formula |
Additional relevant MeSH terms:
|
Hyperbilirubinemia Hyperbilirubinemia, Neonatal Pathologic Processes Infant, Newborn, Diseases Bilirubin |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013