Hyperbilirubinemia, Neonatal Clinical Trial
Official title:
Fenofibrate in Indirect Neonatal Hyperbilirubinemia
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. ;
| 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
|
||
| 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 |
NCT01763632 -
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants
|
N/A | |
| Completed |
NCT01762189 -
The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants
|
N/A | |
| Completed |
NCT06173856 -
Effectiveness of Phototherapy With and Without Probiotics
|
N/A |