Unbound Bilirubin Levels in Healthy Term and Late Preterm... | NCT03237715

Studies
Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

NCT03237715

Sponsor

Rutgers University

Status

Unknown status

Last Update Posted

Aug 2, 2017Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Neonatal Jaundice

Interventions

Assessment of unbound bilirubin levels

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Jun 30, 2019Estimated

Completion Date

Jun 30, 2019Estimated

First Submitted Date

Jul 31, 2017

First Submission Date that Met QC Criteria

Jul 31, 2017

First Posted Date

Aug 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2017

Last Update Posted Date

Aug 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breast fed cohort			Other: Assessment of unbound bilirubin levels
Formula fed cohort			Other: Assessment of unbound bilirubin levels

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessment of unbound bilirubin levels	Other	Collection of residual blood for measurement of unbound bilirubin	Breast fed cohort Formula fed cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Hours

Maximum Age

7 Days

Standard Ages

Child

Study Population

Term and late preterm infants admitted to regular care nursery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robert Wood Johnson University Hospital	Recruiting	New Brunswick	New Jersey	08901	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007567	Jaundice, Neonatal

Ancestor Terms

ID	Term
D051556	Hyperbilirubinemia, Neonatal
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006932	Hyperbilirubinemia

Browse Leaves

Not provided

Browse Branches

Not provided