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Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

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ClinicalTrials.gov Identifier: NCT03237715
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Hegyi, 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.


Condition or disease Intervention/treatment
Neonatal Jaundice Other: Assessment of unbound bilirubin levels

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

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




Primary Outcome Measures :
  1. Unbound bilirubin levels in term and late preterm infants [ Time Frame: Two years ]
  2. Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants [ Time Frame: Two years ]
  3. Effect of phototherapy on unbound bilirubin levels [ Time Frame: Two years ]


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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Term and late preterm infants admitted to regular care nursery
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237715


Locations
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United States, New Jersey
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Thomas Hegyi, MD    732-235-8958    hegyith@rwjms.rutgers.edu   
Sponsors and Collaborators
Rutgers University

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Responsible Party: Thomas Hegyi, Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT03237715     History of Changes
Other Study ID Numbers: 1
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bilirubin
Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs