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

NCT01330667 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-11-15

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Nutramigen Infant Formula

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

Sponsors & Collaborators

Principal Investigators

  • Valerie Flaherman, MD,MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
36 Hours
Max Age
96 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-07-31
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330667 on ClinicalTrials.gov