Neonatal JaundicePhase 4NCT06451900
Role of Fenofibrate in Neonatal Jaundice
A Phase 4 study testing Fenofibrate in people with Neonatal Jaundice, run by Ain Shams University at 1 site in Egypt.
Trial summary
Fenofibrate appears to be an effective and safe drug for the treatment of neonatal hyperbilirubinemia. It has been proven that it decreases the duration of phototherapy and thus shortens the length of hospital stay. Read more about this study
- Who is it for?
- Ages 1 day 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
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 30 Nov 2023
- Phase
- Phase 4
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- full-term (37 to 41 weeks),
- Appropriate for gestational age weight between 2500 to 3500 gm infants
- neonatal hyperbilirubinemia not reaching the level of phototherapy.
Who cannot join
- Newborns with congenital malformations.
- Conjugated hyperbilirubinemia.
- Newborns who need exchange transfusion and phototherapy.
- Newborns presenting with ABO or Rh incompatibility.
- G6PD deficiency.
- Newborns with skin abrasions or infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Role of Fenofibrate in Neonatal Jaundice
Fenofibrate appears to be an effective and safe drug for the treatment of neonatal hyperbilirubinemia. It has been proven that it decreases the duration of phototherapy and thus shortens the length of hospital stay.
This study was performed to study the prophylactic role of fenofibrate in prevention of neonatal jaundice.
Read the detailed description
Neonatal jaundice is a common disease in neonates. Based on current statistics, 60% of term neonates and 80% of preterm neonates suffer from jaundice during the first week of birth The normal bilirubin level of the umbilical cord is 1-3 mg/dL, which increases to 5-6 mg/dL on the second to fourth days after birth and decreases to less than 2 mg/dL on the 5th to 7th days after birth .
Destruction of red blood cell and its hemoglobin component produces bilirubin which is then conjugated to a soluble form and excreted. In neonates, this becomes more significant because of high red cell mass and relative immaturity for bilirubin conjugation.
Free bilirubin deposits in the skin and mucous membranes and produces jaundice. It may also deposit in the brain where it has been implicated in causing transient dysfunction and, occasionally, permanent neuronal damage.
Every year, a huge hospital cost is imposed on parents for the treatment of neonatal jaundice. Moreover, it leads to the mother-child separation and subsequent mental health problems. Proven treatments for jaundice include phototherapy and blood exchange transfusion in which each one has its own complications . medication has also been used to prevent and treat neonatal jaundice Including IVIG, protoporphyrin, phenobarbital and fenofibrate.
Fibrates have been used for several years as a hypolipidemic drug in adults.They exert their hypolipidemic activity through peroxisome proliferator- activated receptor activation The value of this mechanism in the reduction of bile acid synthesis had been demonstrated by experimental study of cindrouk and colleagues . Fibrates also increase bilirubin conjugation and excretion via induction of glucuronyl transferase activity. Its potency to induce bilirubin conjugation is very high. Fibrates are aclass of phenoxy iso butyric acid derivatives including clofibrate and fenofibrate. Fenofibrate is one of the fibrates it has inducing effect on glucuronyl transferase activity, it increases bilirubin conjugation and excretion making it possible to be used in the treatment of neonatal jaundice via influencing bilirubin metabolism. Fenofibrate is very similar to clofibrate in its action. However, it is simply more accessible and has more safety profile, therefore, it is much safer to be given to children than clofibrate. Fenofibrate has been used in treatment of neonatal jaundice the researchers aim to explore its efficiency as a prophylactic agent in neonates with neonatal jaundice not reaching the level of phototherapy.
- Conditions
- Neonatal Jaundice
- Being tested
- Fenofibrate, placebo
- Keywords
- neonatal jaundice, prophylaxis, fenofibrate
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Also called lipid lowering drug
full-term (37 to 41 weeks), Appropriate for gestational age weight between 2500 to 3500 gm infants and with neonatal hyperbilirubinemia not reaching the level of phototherapy were randomised to receive the drug in different doses or in the control group
placeboOther
Also called control
ull-term (37 to 41 weeks), Appropriate for gestational age weight between 2500 to 3500 gm infants and with neonatal hyperbilirubinemia not reaching the level of phototherapy were randomised to receive the drug in different doses or in the control group
| Study group | Role | What they receive |
|---|---|---|
| fenofibrate single dose | Experimental | full term neonates will receive a single oral dose of 10 mg/kg of non- micronized fenofibrate Receives: Drug: Fenofibrate |
| fenofibrate double dose | Experimental | full term neonates will receive two oral doses of 10 mg/kg of non - micronized fenofibrate. Receives: Drug: Fenofibrate |
| placebo | Placebo comparator | full term neonates will receive equivalent amount of distilled water. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in total serum bilirubin
Decline in total serum bilirubin values per unit of time after 12, 24, 36, 48 hours, 5 days from intervention.
Measured: up to 5 days
start of phototherapy
time at which phototherapy will be initiated from receiving the drug and till 5 days later
Measured: up to 5 days
start of exchange transfusion
time at which patient needed to perform exchange transfusion after receiving the drug till five days later
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jul 2023
- Primary completion20 Nov 2023
- Study completion30 Nov 2023
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.
- More trials run by Ain Shams 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- full-term (37 to 41 weeks),Appropriate for gestational age weight between 2500 to 3500 gm infants with neonatal hyperbilirubinemia not reaching thel evel of phototherapy.The participants in our study will be divided in to three groups: Group A: full term neonates received a single oral dose of 10 mg/kg of non- micronized fenofibrate Group B: full term neonates received two oral doses of 10 mg/kg of non - micronized fenofibrate. Group C: full term neonates received equivalent amount of distilled water.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ibrahim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451900
- Sponsor's protocol ID
- prophylactic fenofibrate
- Status last verified
- Jun 2024
- First submitted
- 11 Mar 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be provided when requested appropriately for reasonable reasons from the main investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Role of Fenofibrate in Neonatal Jaundice
- ClinicalTrials.gov ID
- NCT06451900
- Acronym / sponsor ID
- prophylactic fenofibrate
- Conditions
- Neonatal Jaundice
- Keywords
- neonatal jaundice, prophylaxis, fenofibrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 11 Jun 2024 (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.
Fenofibrate appears to be an effective and safe drug for the treatment of neonatal hyperbilirubinemia. It has been proven that it decreases the duration of phototherapy and thus shortens the length of hospital stay.
This study was performed to study the prophylactic role of fenofibrate in prevention of neonatal jaundice.
Detailed description
Neonatal jaundice is a common disease in neonates. Based on current statistics, 60% of term neonates and 80% of preterm neonates suffer from jaundice during the first week of birth The normal bilirubin level of the umbilical cord is 1-3 mg/dL, which increases to 5-6 mg/dL on the second to fourth days after birth and decreases to less than 2 mg/dL on the 5th to 7th days after birth .
Destruction of red blood cell and its hemoglobin component produces bilirubin which is then conjugated to a soluble form and excreted. In neonates, this becomes more significant because of high red cell mass and relative immaturity for bilirubin conjugation.
Free bilirubin deposits in the skin and mucous membranes and produces jaundice. It may also deposit in the brain where it has been implicated in causing transient dysfunction and, occasionally, permanent neuronal damage.
Every year, a huge hospital cost is imposed on parents for the treatment of neonatal jaundice. Moreover, it leads to the mother-child separation and subsequent mental health problems. Proven treatments for jaundice include phototherapy and blood exchange transfusion in which each one has its own complications . medication has also been used to prevent and treat neonatal jaundice Including IVIG, protoporphyrin, phenobarbital and fenofibrate.
Fibrates have been used for several years as a hypolipidemic drug in adults.They exert their hypolipidemic activity through peroxisome proliferator- activated receptor activation The value of this mechanism in the reduction of bile acid synthesis had been demonstrated by experimental study of cindrouk and colleagues . Fibrates also increase bilirubin conjugation and excretion via induction of glucuronyl transferase activity. Its potency to induce bilirubin conjugation is very high. Fibrates are aclass of phenoxy iso butyric acid derivatives including clofibrate and fenofibrate. Fenofibrate is one of the fibrates it has inducing effect on glucuronyl transferase activity, it increases bilirubin conjugation and excretion making it possible to be used in the treatment of neonatal jaundice via influencing bilirubin metabolism. Fenofibrate is very similar to clofibrate in its action. However, it is simply more accessible and has more safety profile, therefore, it is much safer to be given to children than clofibrate. Fenofibrate has been used in treatment of neonatal jaundice the researchers aim to explore its efficiency as a prophylactic agent in neonates with neonatal jaundice not reaching the level of phototherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- full-term (37 to 41 weeks),Appropriate for gestational age weight between 2500 to 3500 gm infants with neonatal hyperbilirubinemia not reaching thel evel of phototherapy.The participants in our study will be divided in to three groups: Group A: full term neonates received a single oral dose of 10 mg/kg of non- micronized fenofibrate Group B: full term neonates received two oral doses of 10 mg/kg of non - micronized fenofibrate. Group C: full term neonates received equivalent amount of distilled water.
| Arm | Type | Receives |
|---|---|---|
| fenofibrate single dose | Experimental | Drug: Fenofibratefull term neonates will receive a single oral dose of 10 mg/kg of non- micronized fenofibrate |
| fenofibrate double dose | Experimental | Drug: Fenofibratefull term neonates will receive two oral doses of 10 mg/kg of non - micronized fenofibrate. |
| placebo | Placebo comparator | Other: placebofull term neonates will receive equivalent amount of distilled water. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- full-term (37 to 41 weeks),
- Appropriate for gestational age weight between 2500 to 3500 gm infants
- neonatal hyperbilirubinemia not reaching the level of phototherapy.
Key exclusion criteria (6 listed)
- Newborns with congenital malformations.
- Conjugated hyperbilirubinemia.
- Newborns who need exchange transfusion and phototherapy.
- Newborns presenting with ABO or Rh incompatibility.
- G6PD deficiency.
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 |
|---|---|---|
| FenofibrateAlso: lipid lowering drugfull-term (37 to 41 weeks), Appropriate for gestational age weight between 2500 to 3500 gm infants and with neonatal hyperbilirubinemia not reaching the level of phototherapy were randomised to receive the drug in different doses or in the control group | Drug | fenofibrate double dose, fenofibrate single dose |
| placeboAlso: controlull-term (37 to 41 weeks), Appropriate for gestational age weight between 2500 to 3500 gm infants and with neonatal hyperbilirubinemia not reaching the level of phototherapy were randomised to receive the drug in different doses or in the control group | Other | placebo |
Primary outcome
change in total serum bilirubin
Time frame: up to 5 days
Decline in total serum bilirubin values per unit of time after 12, 24, 36, 48 hours, 5 days from intervention.
start of phototherapy
Time frame: up to 5 days
time at which phototherapy will be initiated from receiving the drug and till 5 days later
start of exchange transfusion
Time frame: up to 5 days
time at which patient needed to perform exchange transfusion after receiving the drug till five days later
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 11 Jun 2024.
- Individual participant dataSharing planned: No. data will be provided when requested appropriately for reasonable reasons from the main investigator
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenofibrate in people with Neonatal Jaundice, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 6 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 11 Jun 2024. 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 Egypt. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in total serum bilirubin (time frame: up to 5 days). 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 11 Jun 2024.