An interventional study of Fenofibrate Capsules in Hyperbilirubinemia, Neonatal, sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Status unknown. Open to participants aged 2 Days to 7 Days. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Not applicable, Interventional, and Treatment
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.
93 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.
This study's planned enrollment of 60 is below the median of 94 across 59 interventional studies indexed under Hyperbilirubinemia, Neonatal.
Browse Hyperbilirubinemia, Neonatal studies →Shaheed Zulfiqar Ali Bhutto Medical University is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
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EXCLUSION CRITERIA:
Groups A will receive solution A .i.e fenofibrate suspension
Drug: Fenofibrate Capsules
Group B will receive solution B i.e placebo.
Drug: Fenofibrate Capsules
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
Also known as: capsule fenoget
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Shaheed Zulfiqar Ali Bhutto Medical University