Neonatal JaundiceNCT03237715
Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants
An observational study of Neonatal Jaundice, run by Rutgers University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 hours to 7 days
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Assessment of unbound bilirubin levels
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 hours to 7 days
- All sexes
- Child
Study population: Term and late preterm infants admitted to regular care nursery
Who may be able to join
- Term and late-preterm infants admitted to the regular care nursery of Robert Wood Johnson University Hospital will be eligible for the study
Who cannot join
- Infants suffering from genetic, chromosomal or surgical conditions will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Thomas Hegyi, MD, 732-235-8958, hegyith@rwjms.rutgers.edu
About this study
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
- Being tested
- Assessment of unbound bilirubin levels
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of unbound bilirubin levelsOther
Collection of residual blood for measurement of unbound bilirubin
| Study group | Role | What they receive |
|---|---|---|
| Breast fed cohort | Not described Receives: Other: Assessment of unbound bilirubin levels | |
| Formula fed cohort | Not described Receives: Other: Assessment of unbound bilirubin levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unbound bilirubin levels in term and late preterm infants
Measured: Two years
Unbound bilirubin levels in breast-fed versus formula-fed term and late preterm infants
Measured: Two years
Effect of phototherapy on unbound bilirubin levels
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Jul 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Hegyi, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237715
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2017
- First submitted
- 31 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants
- ClinicalTrials.gov ID
- NCT03237715
- Acronym / sponsor ID
- 1
- Conditions
- Neonatal Jaundice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast fed cohort | – | Other: Assessment of unbound bilirubin levels |
| Formula fed cohort | – | Other: Assessment of unbound bilirubin levels |
Who may qualify
- Ages
- 6 hours to 7 days
- Sex
- All
- Age groups
- Child
- Study population
- Term and late preterm infants admitted to regular care nursery
Key inclusion criteria (1 listed)
- Term and late-preterm infants admitted to the regular care nursery of Robert Wood Johnson University Hospital will be eligible for the study
Key exclusion criteria (1 listed)
- Infants suffering from genetic, chromosomal or surgical conditions will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of unbound bilirubin levelsCollection of residual blood for measurement of unbound bilirubin | Other | Breast fed cohort, Formula fed cohort |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Neonatal Jaundice
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wood Johnson University Hospital
New Brunswick, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Jaundice, run by Rutgers University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unbound bilirubin levels in term and late preterm infants (time frame: Two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.