Zinc versus probiotics for newborn jaundice during phototherapy
COMPARATIVE EFFECTS OF ZINC AND PROBIOTICS ON NEONATAL INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
This trial will test whether giving oral zinc or a probiotic helps newborns with indirect jaundice clear bilirubin faster while they receive phototherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | Quaid-e-Azam Medical College Academic / other |
| Locations | 1 site (Bahawalpur, Punjab Province) |
| Trial ID | NCT07102836 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Term or near‑term newborns younger than seven days with indirect hyperbilirubinemia within phototherapy thresholds who are tolerating oral feeds and whose parents consent.
Not a fit: Infants with direct hyperbilirubinemia, suspected or confirmed sepsis, gastrointestinal malformations, oral intolerance, those on mechanical ventilation, or with major congenital anomalies are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, one of these oral supplements could shorten phototherapy time and reduce hospital stays for newborns with indirect jaundice.
How similar studies have performed: Small clinical trials and pilot studies have reported mixed but sometimes modest bilirubin-lowering effects from zinc or probiotics, so the approach has limited and inconsistent prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bahawalpur, Punjab Province
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.