COMPARISON OF ZINC AND PROBIOTICS ON NEONATES WITH INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY

Not Applicable

Recruiting

• Conditions: Indirect Hyperbilirubinemia; Neonatal
• Interventions: Drug: Zinc sulfate; Drug: Probiotic lactobacillus rhamnosus GG

• Registration Number: NCT07102836
• Lead Sponsor: Quaid-e-Azam Medical College

Brief Summary

Study will evaluate effects of oral zinc and probiotics supplementation in neonates who have indirect hyperbilirubinemia and are receiving phototherapy. Aim is to compare efficacy of these two drugs in clearing bilirubin and reducing duration of phototherapy. Neonates will be randomly assigned to receive either drug alongside phototherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Start: 2025-08-07
• Primary Completion: 2026-02-07
• Study Completion: 2026-05-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 1. Term or Near term neonates 2. Age <7 days at enrollment 3. Bilirubin levels within phototherapy range according to NICE bilirubin threshold charts 4. No identifiable pathology 5. Tolerating oral feeds 6. Parental or Guardian written informed consent taken.

Exclusion Criteria

• 1. Positive sepsis screen or clinical signs of infection 2. Direct hyperbilirubinemia 3. Gastrointestinal malformations 4. Oral intolerance 5. Requiring mechanical ventilation 6. Congenital anomalies 7. Parental or Guardian refusal to participate in study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc group	Zinc sulfate	Participants in this group will receive oral zinc following neonatal dosing guidelines.
Probiotics group	Probiotic lactobacillus rhamnosus GG	Participants in this group will receive oral probiotics following neonatal dosing guidelines.

Primary Outcome Measures

Name	Time	Method
Rate of decline in Bilirubin levels during phototherapy with this adjuvant therapy	From initiation of supplementation with phototherapy to its completion (typically 3-7 days).	Primary outcome measures the rate at which total serum bilirubin decreases in mg/dL per day in neonates undergoing phototherapy while receiving supplementation with either zinc or probiotics. Bilirubin levels will be recorded at baseline and at regular intervals until phototherapy is discontinued and hence rate of decline will be calculated.

Trial Locations

Locations (1)

Sadiq Abbasi Hospital, QAMC, Bahawalpur; 🇵🇰 Bahawalpur, Punjab, Pakistan