Melatonin Administration as an Adjuvant Therapy in Preterm Infants with Neonatal Jaundice

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231210060317N1

Enrollment

Registered

2023-12-24

Start date

2024-01-20

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Neonatal jaundice. Neonatal jaundice associated with preterm delivery

Interventions

Intervention 1: Intervention group: Neonates in this group will receive 0.5 mg/kg/day oral melatonin drops in addition to phototherapy. Intervention 2: Control group: Neonates in this group will only

Eligibility

Sex/Gender

All

Age

3 Days to 30 Days

Inclusion criteria

Inclusion criteria: Gestational age 32-37 weeks Serum bilirubin level below exchange transfusion threshold Indirect hyperbilirubinemia Postnatal age under 30 days

Exclusion criteria

Exclusion criteria: Underlying diseases and congenital anomalies in the neonate Any signs of neonatal sepsis or other infections Signs and risk factors of hemolysis Acute or chronic respiratory diseases

Design outcomes

Primary

Measure	Time frame
Serum bilirubin level (mg/dL). Timepoint: Serum bilirubin levels will be measured in both groups before the intervention (T0), on the first day (T1), and on the second day (T2) after the intervention. Method of measurement: Blood test.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzaneh Ahmadi Khatiri

Shahid Beheshti University of Medical Sciences

Ahmadikhatiri@sbmu.ac.ir+98 21 2222 7033

Outcome results

None listed

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