Clinical Trials Logo
  1. Home
  2. Neonatal Jaundice
  3. NCT03237715
  4. Details
NCT03237715 Clinical Trial

Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Neonatal Jaundice Clinical Trial

Official title:
Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03237715
Other study ID # 1
Secondary ID
Status Recruiting
Phase N/A
First received July 31, 2017
Last updated July 31, 2017
Start date July 1, 2017
Est. completion date June 30, 2019

Study information
Verified date July 2017
Source Rutgers University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers
Gender All
Age group N/A to 7 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Assessment of unbound bilirubin levels
Collection of residual blood for measurement of unbound bilirubin

Locations
Country Name City State
United States Robert Wood Johnson University Hospital New Brunswick New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Rutgers University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Unbound bilirubin levels in term and late preterm infants Two years
Primary Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants Two years
Primary Effect of phototherapy on unbound bilirubin levels Two years
See also
  Status Clinical Trial Phase
Recruiting NCT04365998 - BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice N/A
Completed NCT02222805 - Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment N/A
Completed NCT01622699 - Implementation of a Transcutaneous Bilirubinometer N/A
Completed NCT00692224 - Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial Phase 1/Phase 2
Not yet recruiting NCT06080971 - Persistent Neonatal Jaundice on Neonates and Childern
Recruiting NCT06075290 - the Difference of Follow-up Methods of Neonatal Jaundice
Recruiting NCT05955144 - Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones N/A
Recruiting NCT05127070 - Evaluating the NeoTree in Malawi and Zimbabwe
Completed NCT03306004 - Neonatal Jaundice: Knowledge, Attitudes and Practices of Mothers and Medical Trainees and Providers in and Around Ogbomosho N/A
Completed NCT02774434 - Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age N/A
Terminated NCT05365399 - Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population N/A
Recruiting NCT03933423 - Home Based Phototherapy for Neonatal Jaundice N/A
Recruiting NCT06087874 - Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice Phase 2
Recruiting NCT06399146 - Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana N/A
Recruiting NCT03183986 - Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm. N/A
Withdrawn NCT00917007 - Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
Completed NCT06227624 - Role of Oral Zinc in Reducing Neonatal Indirect Hyperbilirubinemia Phase 3
Completed NCT04433923 - Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants N/A
Completed NCT04418180 - Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants N/A
Completed NCT06386731 - Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice N/A