Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

July 31, 2017 updated by: Thomas Hegyi, Rutgers University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 hours to 1 week (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Term and late preterm infants admitted to regular care nursery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast fed cohort
Other: Assessment of unbound bilirubin levels
Collection of residual blood for measurement of unbound bilirubin
Formula fed cohort
Other: Assessment of unbound bilirubin levels
Collection of residual blood for measurement of unbound bilirubin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unbound bilirubin levels in term and late preterm infants
Time Frame: Two years
Two years
Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants
Time Frame: Two years
Two years
Effect of phototherapy on unbound bilirubin levels
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ANTICIPATED)

June 30, 2019

Study Completion (ANTICIPATED)

June 30, 2019

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (ACTUAL)

August 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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