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NCT03237715 Clinical Trial

Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Neonatal Jaundice Clinical Trial

Official title:
Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03237715
Other study ID # 1
Secondary ID
Status Recruiting
Phase N/A
First received July 31, 2017
Last updated July 31, 2017
Start date July 1, 2017
Est. completion date June 30, 2019

Study information
Verified date July 2017
Source Rutgers University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers
Gender All
Age group N/A to 7 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Assessment of unbound bilirubin levels
Collection of residual blood for measurement of unbound bilirubin

Locations
Country Name City State
United States Robert Wood Johnson University Hospital New Brunswick New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Rutgers University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Unbound bilirubin levels in term and late preterm infants Two years
Primary Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants Two years
Primary Effect of phototherapy on unbound bilirubin levels Two years
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