Recruiting

Unbound Bilirubin

Sponsor:

Rutgers University

Code:

NCT03237715

Conditions

Neonatal Jaundice

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Assessment of unbound bilirubin levels

Study Details

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.

Conditions

Neonatal Jaundice

Study ID

NCT03237715

Start date

Jul 1, 2017

Status verified date

Jul, 2017

Completion date

Jun 30, 2019

Anticipated

Primary completion date

Jun 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Arms

Breast fed cohort

Formula fed cohort

Interventions

Assessment of unbound bilirubin levels

Collection of residual blood for measurement of unbound bilirubin

Primary outcome measure

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

Central Contacts and Locations

Locations

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Thomas Hegyi, MD

732-235-8958hegyith@rwjms.rutgers.edu

More Information

Sponsor

Rutgers University

Last update posted

Aug 2, 2017

Last verified

Jul, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers University on 2017-08-02.