Jaundice, Neonatal
Conditions
Keywords
indirect hyperbilirubinemia, fenofibrate+phototherapy, phenobarbitone+phototherapy
Brief summary
This is a prospective, randomized, open-label controlled trial comparing fenofibrate (10 mg/kg) and phenobarbitone (3 mg/kg) as adjuncts to conventional phototherapy in neonates with unconjugated hyperbilirubinemia. The study aims to compare their effectiveness in reducing total serum bilirubin. Secondary outcomes include duration of phototherapy, length of hospital stay, and treatment-related adverse effects.
Detailed description
Neonatal hyperbilirubinemia is one of the most common conditions requiring medical attention during the neonatal period. Although phototherapy is the standard treatment for uncomplicated indirect hyperbilirubinemia, adjuvant pharmacological therapies may enhance bilirubin clearance and reduce the duration of phototherapy and hospital stay. Fenofibrate induces hepatic enzymes involved in bilirubin conjugation and excretion, whereas phenobarbitone has traditionally been used to increase bilirubin metabolism through enzyme induction. The comparative effectiveness of these two agents as adjuncts to phototherapy has not been adequately evaluated. This Phase IV, prospective, randomized, open-label, parallel-group clinical trial aims to compare the efficacy and safety of fenofibrate versus phenobarbitone as adjuncts to conventional phototherapy in neonates with indirect hyperbilirubinemia. Eligible neonates will be randomly assigned in a 1:1 ratio to receive either fenofibrate plus phototherapy or phenobarbitone plus phototherapy. The primary outcome is the reduction in total serum bilirubin. Secondary outcomes include the duration of phototherapy, length of hospital stay, need for exchange transfusion (if applicable), and the occurrence of adverse events. Participants will be followed until resolution of hyperbilirubinemia and discharge according to the study protocol. The results of this study are expected to provide evidence regarding the more effective adjunctive therapy for the management of neonatal indirect hyperbilirubinemia.
Interventions
DRUGFenofibrate + Phototherapy
Participants randomized to the experimental group will receive a single oral dose of fenofibrate in addition to standard phototherapy. Phototherapy will be administered according to the hospital's neonatal jaundice management protocol. Clinical assessment and serial total serum bilirubin measurements will be performed as per the study protocol until the infant meets the criteria for discontinuation of phototherapy and discharge.
DRUGPhenobarbitone + Phototherapy
Participants randomized to the active comparator group will receive oral phenobarbitone in addition to standard phototherapy. Phototherapy will be administered according to the hospital's neonatal jaundice management protocol. Clinical assessment and serial total serum bilirubin measurements will be performed as per the study protocol until the infant meets the criteria for discontinuation of phototherapy and discharge.
Sponsors
Rubab Fatima
Sheikh Zayed Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled trial, having sample size of 70 patients, eligible neonates will be recruited through non-probability consecutive sampling and randomly allocated in a 1:1 ratio to Group A or Group B using the lottery method.
Eligibility
Sex/Gender
ALL
Age
24 Years to 14 Days
Healthy volunteers
No
Inclusion criteria
* Term neonates aged 24 hours to 14 days with gestational age 37-42 weeks. * Birth weight ≥2500 g. * Physiological, non-haemolytic indirect hyperbilirubinemia with total serum bilirubin 15-20 mg/dL, requiring phototherapy according to age-specific guidelines. * Written informed consent from parents or legal guardian.
Exclusion criteria
* Preterm or low-birth-weight neonates. * Jaundice appearing within the first 24 hours of life. * ABO or Rh incompatibility, positive direct Coombs test, or any evidence of haemolysis. * Neonates with sepsis, birth asphyxia, shock, congenital anomalies, cholestasis, liver or renal disease. * Neonates with electrolyte, acid-base, coagulation, or intrauterine infection-related disorders. * Previous neonatal use of fenofibrate or phenobarbitone, or maternal phenobarbitone use during pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total serum bilirubin (TSB) | Baseline and at 48 hours after initiation of treatment | Change in total serum bilirubin (TSB) level during treatment (serial measurements and comparison between groups). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of phototherapy | From initiation untill discontinuation of phototherapy during index hospitalization(approximately upto 72 hours) | Duration of phototherapy given to neonates |
| Duration of Hospital Stay | From hospital admission untill hospital discharge during index hospitalization(approximatley upto 5 days) | Date of admission of neonate till its discharge date will be calculated as the hospital stay of neonate |
| Safety profile (adverse effects) including: Skin rash, Dehydration, Gastrointestinal symptoms, Hepatotoxicity, Renal impairment, Hypoglycemia, Sedation | Baseline and through 48 hours after initiation of treatment | Assessment of the safety of fenofibrate and phenobarbitone by monitoring the incidence of treatment-related adverse events, including skin rash, dehydration, gastrointestinal symptoms, hepatotoxicity, renal impairment, hypoglycemia, and sedation during the study period. |
Contacts
CONTACTRubab Fatima Postgradue Trainee, MBBS
Outcome results
None listed