Clinical trial NCT01330667: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Hyperbilirubinemia, Neonatal
Keywords: Hyperbilirubinemia
Breastfeeding
Limited Formula
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 36
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: TSB meeting or exceeding AAP-recommended phototherapy treatment threshold.
timeFrame: Up to two weeks after birth
Secondary outcomes:
measure: Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy
timeFrame: Up to three months after birth
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Valerie Flaherman, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: