Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

NCT ID: NCT03237715

Last Updated: 2017-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-06-30

Brief Summary

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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

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Conditions

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Neonatal Jaundice

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast fed cohort

Assessment of unbound bilirubin levels

Intervention Type OTHER

Collection of residual blood for measurement of unbound bilirubin

Formula fed cohort

Assessment of unbound bilirubin levels

Intervention Type OTHER

Collection of residual blood for measurement of unbound bilirubin

Interventions

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Assessment of unbound bilirubin levels

Collection of residual blood for measurement of unbound bilirubin

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Hours

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Hegyi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Thomas Hegyi, MD

Role: primary

732-235-8958

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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