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Evaluating the effect of low dose vs moderate dose clofibrate on decreasing serum bilirubin in healthy full term neonates

Evaluating the effect of low dose vs moderate dose clofibrate on decreasing serum bilirubin in healthy full term neonates

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012092910933N1
Enrollment
132
Registered
2012-10-25
Start date
2008-09-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal jaundice. P59.9 Neonatal jaundice, unspecified

Interventions

Intervention 1: control group receiving only phototherapy. Intervention 2: intervention group 1 receiving a single low dose of oral clofibrate (25 mg/kg) plus phototherapy. Intervention 3: interventi
Treatment - Drugs
control group receiving only phototherapy
intervention group 1 receiving a single low dose of oral clofibrate (25 mg/kg) plus phototherapy
intervention group 2 receiving a single moderate dose of oral clofibrate (50 mg/kg) plus phototherapy.

Sponsors

Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria included: (a) age of 2 to 29 days; (b) full term newborn (gestational age between 38 to 40 weeks); (c) weight of 2500 to 4000 gr; having indirect hyperbilirubinemia (TSB>16 mg/dl) ; (d) absence of hemolysis, ABO or Rh incompatibility; (e) negative coomb’s test; (f) reticulocyte count less than 5%. Exclusion criteria : The neonates with sign of sepsis, electrolyte impairment, any congenital anomalies or disease, seizure, formula feeding, hemolytic disease and those who need exchange transfusion were excluded from the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Bilirubin. Timepoint: Total and indirect bilirubin levels were measured at the beginning of treatment and then 12, 24, 36 and 48 hours later. Method of measurement: RA1000 Techinca.

Secondary

MeasureTime frame
Bilirubin. Timepoint: Total and indirect bilirubin levels were measured at the beginning of treatment and then 12, 24, 36 and 48 hours later. Method of measurement: RA1000 Techinca.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Fatemeh Eghbalian

Hamadan University of Medical Siences

eghbalian_fa@yahoo.com+98 81 1822 3978

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026