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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-07

Study Completion Date

2026-05-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Indirect Hyperbilirubinemia Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to two groups. One group will receive Zinc and other will be receiving Probiotics. This will be done in continuation of Phototherapy to compare the effects of both drugs in reducing indirect hyperbilirubinemia.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Both participants and care provider will be blinded to intervention allocation. Preparation of both drugs will be made identical in appearance and packaging to ensure unbiased administration and assessment during phototherapy.

Study Groups

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Zinc group

Participants in this group will receive oral zinc following neonatal dosing guidelines.

Group Type EXPERIMENTAL

Zinc sulfate

Intervention Type DRUG

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

Probiotics group

Participants in this group will receive oral probiotics following neonatal dosing guidelines.

Group Type EXPERIMENTAL

Probiotic lactobacillus rhamnosus GG

Intervention Type DRUG

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

Interventions

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Zinc sulfate

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

Intervention Type DRUG

Probiotic lactobacillus rhamnosus GG

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

Intervention Type DRUG

Other Intervention Names

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ZnSO4 Zinc LGG L. rhamnosus GG Probiotic

Eligibility Criteria

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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

Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No