COMPARISON OF ZINC AND PROBIOTICS ON NEONATES WITH INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-28
SponsorQuaid-e-Azam Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Zinc sulfate
DrugOral zinc sulfate syrup in a dose providing 5mg elemental zinc daily as adjuvant to phototherapy.
Probiotic lactobacillus rhamnosus GG
DrugOral Probiotic Lactobacillus rhamnosus GG drops daily as adjuvant to phototherapy.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Zinc groupExperimental treatment 1 intervention
Group B: Probiotics groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of decline in Bilirubin levels during phototherapy with this adjuvant therapy
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.
Time frame
From initiation of supplementation with phototherapy to its completion (typically 3-7 days).Sponsors and contacts
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Source ClinicalTrials.gov