Fenofibrate accelerates bilirubin conjugation and excretion, decreasing the side effects of prolonged unconjugated hyperbilirubinemia in neonates. It also reduces the duration of phototherapy and thus the duration of stay in the hospital. This research is carried out to improve standard protocol for the management of neonatal hyperbilirubinemia in the local settings.
Complete history and examination will be carried out while patients will be screened for enrollment. After taking informed consent, eligible patients will be selected and divided into two groups A and B by lottery method. Demographics like name, age (hours), gender, birth weight, and gestational age will be noted. Solutions will be prepared in the required strengths and labeled accordingly. Groups A will receive Solution A i.e. Fenofibrate suspension is prepared by dissolving 200 mg capsule in 10 ml distilled water and given as a single dose of 10mg/kg (0.5 ml/kg) and Group B will receive solution B i.e. 0.5ml/ kg normal saline as a placebo. Both groups will receive LED phototherapy under standard conditions. The serum bilirubin level will be noted at the time of admission and then at 12hr, 24hr, and 48 hours of treatment. All this information will be recorded on proforma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Solutions will be prepared in the required strengths and labeled accordingly. Group A will receive Solution A i.e. Fenofibrate suspension is prepared by dissolving 200 mg capsule in 10 ml distilled water and given as a single dose of 10mg/kg (0.5 ml/kg) and Group B will receive solution B i.e. 0.5ml/ kg normal saline as a placebo. Both groups will receive LED phototherapy under standard conditions. The serum bilirubin level will be noted at the time of admission and then at 12hr, 24hr, and 48 hours of treatment
Duration of phototherapy
It is the total time from admission (Serum bilirubin level ≥15 and ≤20 mg/dl) until phototherapy is no longer needed (Serum bilirubin level \< 10mg/dl) and is measured in hours.
Time frame: 6 months
Serum bilirubin level
It will be measured at the time of admission and then at 12hr, 24hr, and 48 hours of treatment.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.