Neonatal Jaundice. Neonatal jaundice from other and unspecified causes
Conditions
Interventions
Intervention 1: Control group: Neonates in this group receive standard phototherapy alone and, to maintain blinding, are administered a placebo drop identical in appearance and volume to Bili-Cut drop
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Days to 14 Days
Inclusion criteria
Inclusion criteria: Healthy term neonates with gestational age of 37-41 weeks Age between 2 and 14 days at the time of enrollment Birth weight between 2500 and 4000 grams Total serum bilirubin level between 15 and 20 mg/dL Non-hemolytic (non-immune) neonatal jaundice Passage of first meconium prior to enrollment Exclusive breastfeeding Eligibility for phototherapy based on standard clinical guidelines Written informed consent obtained from parents or legal guardians
Exclusion criteria
Exclusion criteria: History of perinatal asphyxia Proven or suspected neonatal infection or sepsis Major congenital anomalies Previous exchange transfusion Conjugated (direct) hyperbilirubinemia ABO or Rh blood group incompatibility Known hypersensitivity to study medications Severe dehydration or electrolyte imbalance History of using medications affecting bilirubin levels prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in serum total bilirubin levels in neonates. Timepoint: 12, 24, and 48 hours after intervention initiation. Method of measurement: Measurement of serum total bilirubin via blood sampling and standard hospital laboratory methods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hospital stay. Timepoint: Until hospital discharge. Method of measurement: Hospital stay duration recorded from medical records.;Frequency and severity of adverse events including diarrhea, vomiting, and dehydration. Timepoint: Throughout hospitalization and 2 days post-discharge. Method of measurement: Clinical assessment and documentation using study-specific forms.;Number of bowel movements and stool consistency (normal, soft, watery). Timepoint: During hospitalization. Method of measurement: Recording stool frequency and consistency by trained nursing staff.;Changes in serum levels of S100B and NSE proteins. Timepoint: During hospitalization at the time of serum sampling. Method of measurement: Measurement of serum S100B and NSE levels using standard ELISA kits. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAlireza Zali
Shahid Beheshti University of Medical Sciences
Outcome results
None listed