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

Phase 2RecruitingNCT07102836

Quaid-e-Azam Medical College110 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Indirect Hyperbilirubinemia Neonatal

Interventions

Zinc sulfateDRUG

Oral zinc sulfate syrup in a dose providing 5mg elemental zinc daily as adjuvant to phototherapy.

Probiotic lactobacillus rhamnosus GGDRUG

Oral Probiotic Lactobacillus rhamnosus GG drops daily as adjuvant to phototherapy.

Eligibility

Sex: ALLMin age: 0 DaysMax age: 28 Days

Medical Language ↔ Plain English

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

Locations (1)

Sadiq Abbasi Hospital, QAMC, Bahawalpur

Bahawalpur, Punjab Province, Pakistan

RECRUITING

Outcomes

Primary Outcomes

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).

Central Contacts

Malik M. Umair Fazal, MBBS, FCPS Paediatrics

CONTACT

+923318682681 umair.malik1622@gmail.com

Dr. Muhammad Anwar, MBBS, FCPS Neonatology

CONTACT

+923216820943 hmanwar157@yahoo.com

Data from ClinicalTrials.gov

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