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Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03237715
Enrollment
180
Registered
2017-08-02
Start date
2017-07-01
Completion date
2019-06-30
Last updated
2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Jaundice

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.

Interventions

OTHERAssessment of unbound bilirubin levels

Collection of residual blood for measurement of unbound bilirubin

Sponsors

Rutgers University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Hours to 7 Days

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.

Design outcomes

Primary

MeasureTime frame
Unbound bilirubin levels in term and late preterm infantsTwo years
Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infantsTwo years
Effect of phototherapy on unbound bilirubin levelsTwo years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026