NCT03237715

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

July 31, 2017

Last Update Submit

July 31, 2017

Conditions

Neonatal Jaundice

Outcome Measures

Primary Outcomes (3)

  • Unbound bilirubin levels in term and late preterm infants

    Two years

  • Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants

    Two years

  • Effect of phototherapy on unbound bilirubin levels

    Two years

Study Arms (2)

Breast fed cohort

Other: Assessment of unbound bilirubin levels

Formula fed cohort

Other: Assessment of unbound bilirubin levels

Interventions

Assessment of unbound bilirubin levelsOTHER

Collection of residual blood for measurement of unbound bilirubin

Breast fed cohortFormula fed cohort

Eligibility Criteria

Age6 Hours - 7 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Term and late preterm infants admitted to regular care nursery

You may qualify if:

  • Term and late-preterm infants admitted to the regular care nursery of Robert Wood Johnson University Hospital will be eligible for the study

You may not qualify if:

  • Infants suffering from genetic, chromosomal or surgical conditions will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, NeonatalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 2, 2017

Study Start

July 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 2, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)