Neonatal JaundiceNCT04418180
Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants
A study testing Fenofibrate in people with Neonatal Jaundice, run by Mansoura University.
Trial summary
Background: Despite widespread phototherapy usage, many newborn infants remain in need of other lines of invasive therapy such as intravenous immunoglobulins and exchange transfusions. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 12 Dec 2018
- Phase
- Interventional
- 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 Up to 28 days
- All sexes
- Child
Who may be able to join
- we included appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinemia who are candidate for phototherapy according to American academy of pediatrics guidelines
Who cannot join
- Full term infants with intrauterine growth restriction, congenital malformations, conjugated hyperbilirubinemia, severe jaundice initially required exchange transfusion, skin abrasions or infection, and preterm infants were excluded
About this study
Official title: Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.
Background: Despite widespread phototherapy usage, many newborn infants remain in need of other lines of invasive therapy such as intravenous immunoglobulins and exchange transfusions.
Objective: To assess the efficacy and the safety of adding fenofibrate to phototherapy for treatment of pathological jaundice in full term infants.
Design/Methods: We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU of Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg /kg /day for one day or two days or placebo. Primary outcome was total serum bilirubin values after 12, 24, 36, 48 hours from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate.
- Conditions
- Neonatal Jaundice
- Being tested
- Fenofibrate, Placebo
- Keywords
- Fenofibrate, Neonatal hyperbilirubinemia, Phototherapy
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr
PlaceboDrug
oral distilled water
| Study group | Role | What they receive |
|---|---|---|
| GROUP1 | Active comparator | group receiving single dose fenofibrate Receives: Drug: Fenofibrate |
| GROUP2 | Active comparator | group receiving double dose fenofibrate Receives: Drug: Fenofibrate |
| GROUP3 | Placebo comparator | photo therapy only Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total serum bilirubin
measure level of serum total bilirubin (mg/dl)
Measured: 24 hours of treatment
Total serum bilirubin
measure level of serum total bilirubin (mg/dl)
Measured: 48 hours of treatment
Total serum bilirubin
measure level of serum total bilirubin (mg/dl)
Measured: 72 hours of treatment
Secondary outcomes (2)
length of hospital stay
Duration of hospital admission (days)
Measured: expected 3 days of treatment
duration of photo therapy
duration of photo therapy (hours)
Measured: expected 48 hours of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jun 2016
- Primary completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd Elazeez Attala Shabaan, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418180
- Sponsor's protocol ID
- MansouraU003
- Status last verified
- Jun 2020
- First submitted
- 29 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Awad MH, Amer S, Hafez M, Nour I, Shabaan A. "Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.". J Perinatol. 2021 Apr;41(4):865-872. doi: 10.1038/s41372-020-00861-2. Epub 2020 Oct 17.
PubMed 33070152
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04418180
- Acronym / sponsor ID
- MansouraU003
- Conditions
- Neonatal Jaundice
- Keywords
- Fenofibrate, Neonatal hyperbilirubinemia, Phototherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- First posted
- 5 Jun 2020 (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.
Background: Despite widespread phototherapy usage, many newborn infants remain in need of other lines of invasive therapy such as intravenous immunoglobulins and exchange transfusions.
Objective: To assess the efficacy and the safety of adding fenofibrate to phototherapy for treatment of pathological jaundice in full term infants.
Design/Methods: We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU of Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg /kg /day for one day or two days or placebo. Primary outcome was total serum bilirubin values after 12, 24, 36, 48 hours from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP1 | Active comparator | Drug: Fenofibrategroup receiving single dose fenofibrate |
| GROUP2 | Active comparator | Drug: Fenofibrategroup receiving double dose fenofibrate |
| GROUP3 | Placebo comparator | Drug: Placebophoto therapy only |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- we included appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinemia who are candidate for phototherapy according to American academy of pediatrics guidelines
Key exclusion criteria (1 listed)
- Full term infants with intrauterine growth restriction, congenital malformations, conjugated hyperbilirubinemia, severe jaundice initially required exchange transfusion, skin abrasions or infection, and preterm infants were 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 |
|---|---|---|
| FenofibratePatients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr | Drug | GROUP1, GROUP2 |
| Placebooral distilled water | Drug | GROUP3 |
Primary outcome
Total serum bilirubin
Time frame: 24 hours of treatment
measure level of serum total bilirubin (mg/dl)
Total serum bilirubin
Time frame: 48 hours of treatment
measure level of serum total bilirubin (mg/dl)
Total serum bilirubin
Time frame: 72 hours of treatment
measure level of serum total bilirubin (mg/dl)
2 secondary outcomes
length of hospital stay
Time frame: expected 3 days of treatment
duration of photo therapy
Time frame: expected 48 hours of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Derived from this study: PubMed 33070152Awad MH, Amer S, Hafez M, Nour I, Shabaan A. "Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.". J Perinatol. 2021 Apr;41(4):865-872. doi: 10.1038/s41372-020-00861-2. Epub 2020 Oct 17.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fenofibrate in people with Neonatal Jaundice, run by Mansoura University.
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: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total serum bilirubin (time frame: 24 hours of treatment). 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?
On the ClinicalTrials.gov record for NCT04418180, which also lists 1 linked publication.
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 5 Jun 2020.