Zinc versus probiotics for newborn jaundice during phototherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized interventional trial will assign term or near-term neonates with indirect hyperbilirubinemia to receive either oral zinc sulfate or Lactobacillus rhamnosus GG alongside standard phototherapy. The main outcomes include rate of bilirubin decline and total duration of phototherapy required. Eligible infants are under seven days old, tolerating feeds, have bilirubin levels meeting phototherapy thresholds, and have no identifiable pathology. The trial is conducted at a single center in Bahawalpur, Pakistan.

Why it matters

Who can join: the full rules

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

Where it's running

• Sadiq Abbasi Hospital, QAMC, Bahawalpur
  Bahawalpur, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Malik M. Umair Fazal, MBBS, FCPS Paediatrics — Quaid-e-Azam Medical College
• Study coordinator: Malik M. Umair Fazal, MBBS, FCPS Paediatrics
• Email: umair.malik1622@gmail.com
• Phone: +923318682681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.