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Efficacy of combination treatment of phenobarbital and phototherapy in non-hemolytic hyperbilirubinemia of term neonates

Efficacy of combination treatment of phenobarbital and phototherapy in non-hemolytic hyperbilirubinemia of term neonates

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130812014333N231
Enrollment
50
Registered
2024-10-24
Start date
2024-11-05
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Hyper bilirubinemia. Neonatal jaundice, unspecified

Interventions

Intervention 1: The first intervention group will receive 10 mg/kg of phenobarbital by injection in the quadriceps muscle and then 3 mg/kg orally in two doses every 12 hours. Intervention 2: The secon

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Days to 8 Days

Inclusion criteria

Inclusion criteria: Informed consent of the infant's parents Babies over 37 weeks old, 2-8 days old Primary bilirubin 15 to 25 mg/dL

Exclusion criteria

Exclusion criteria: History of phenobarbital use by the mother during pregnancy or use of phenobarbital for the baby for any reason, such as neonatal convulsions Presence of organomegaly adrenal hematoma and cephalhematoma History of phototherapy or previous blood exchange Blood dyscrasias

Design outcomes

Primary

MeasureTime frame
Blood bilirubin level. Timepoint: upon arrival and 6, 12, 24, 36, 48 and 72 hours (if hospitalized for at least 36 hours) after the start of the study. Method of measurement: Blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mazyar Vakili Amini

Kermanshah University of Medical Sciences

mzvakilia@kums.ac.ir+98 83 3721 8202

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026