COMPARISON OF ZINC AND PROBIOTICS ON NEONATES WITH INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zinc sulfate, Probiotic lactobacillus rhamnosus GG.
- Who it may be relevant to
- Registry conditions: Indirect Hyperbilirubinemia, Neonatal. Basic parameters: 0 Days — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COMPARATIVE EFFECTS OF ZINC AND PROBIOTICS ON NEONATAL INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
Overview
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.
Interventions
- Drug Zinc sulfate
Oral zinc sulfate syrup in a dose providing 5mg elemental zinc daily as adjuvant to phototherapy. - Drug Probiotic lactobacillus rhamnosus GG
Oral Probiotic Lactobacillus rhamnosus GG drops daily as adjuvant to phototherapy.
Primary outcome measures
- Rate of decline in Bilirubin levels during phototherapy with this adjuvant therapy [Time frame: From initiation of supplementation with phototherapy to its completion (typically 3-7 days).]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Sadiq Abbasi Hospital, QAMC, Bahawalpur — Bahawalpur
Identifiers
NCT: NCT07102836 · QAMC-CT-01 · 248/DME/QAMC Bahawalpur