Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

• Conditions: Neonatal Jaundice
• Interventions: Other: Assessment of unbound bilirubin levels

• Registration Number: NCT03237715
• Lead Sponsor: Rutgers University

Brief Summary

Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in term and late preterm infants during the first week of life.

Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their relationship to unbound fatty acid (FFAu) levels.

Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-01
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Last Update Submitted: 2017-07-31
• Study First Posted: 2017-08-02
• Last Update Posted: 2017-08-02
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Term and late-preterm infants admitted to the regular care nursery of Robert Wood Johnson University Hospital will be eligible for the study

Exclusion Criteria

• Infants suffering from genetic, chromosomal or surgical conditions will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast fed cohort	Assessment of unbound bilirubin levels	-
Formula fed cohort	Assessment of unbound bilirubin levels	-

Primary Outcome Measures

Name	Time	Method
Effect of phototherapy on unbound bilirubin levels	Two years
Unbound bilirubin levels in term and late preterm infants	Two years
Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants	Two years

Trial Locations

Locations (1)

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States