Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04868019
Study type Interventional
Source Shaheed Zulfiqar Ali Bhutto Medical University
Contact
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date February 2022

See also
  Status Clinical Trial Phase
Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Completed NCT02000830 - Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
Completed NCT01887327 - Stannsoporfin With Light Therapy for Newborn Babies With Jaundice Phase 2
Completed NCT05356273 - The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy N/A
Suspended NCT03741803 - Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice N/A
Recruiting NCT03876678 - The Efficacy of Oral Probiotics on Neonatal Hyperbilirubinemia N/A
Not yet recruiting NCT05365984 - Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications N/A
Recruiting NCT04251286 - Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network
Completed NCT03723005 - A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
Recruiting NCT06087874 - Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice Phase 2
Completed NCT03624335 - Influence of Umbilical Cord Clamping Time in the Newborn N/A
Recruiting NCT06324799 - The Effect of Position Change Frequency on Hyperbilirubinemia N/A
Recruiting NCT06209489 - White Cover and Massage Impact on Bilirubin Levels and Phototherapy Duration in Newborns N/A
Completed NCT03824990 - Multi-center Clinical Study on Neonatal Hyperbilirubinemia N/A
Withdrawn NCT01330667 - Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia N/A
Completed NCT01169740 - Transcutaneous Measurement of Jaundice in the Newborn N/A
Recruiting NCT06238349 - Hyperbilirubinemia in Full-term Neonates Phase 4
Completed NCT03007563 - Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice N/A
Completed NCT01762189 - The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants N/A
Completed NCT01763632 - Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants N/A