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| ID | Type | Description | Link |
|---|---|---|---|
| 248/DME/QAMC Bahawalpur | Other Identifier | DEPARTMENT OF MEDICAL EDUCATION QAMC BAHAWALPUR |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc group | Experimental | Participants in this group will receive oral zinc following neonatal dosing guidelines. |
|
| Probiotics group | Experimental | Participants in this group will receive oral probiotics following neonatal dosing guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc sulfate | Drug | Oral zinc sulfate syrup in a dose providing 5mg elemental zinc daily as adjuvant to phototherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From initiation of supplementation with phototherapy to its completion (typically 3-7 days). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malik M. Umair Fazal, MBBS, FCPS Paediatrics | Contact | +923318682681 | +92622720235 | umair.malik1622@gmail.com |
| Dr. Muhammad Anwar, MBBS, FCPS Neonatology | Contact | +923216820943 | +92622720235 | hmanwar157@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Malik M. Umair Fazal, MBBS, FCPS Paediatrics | Quaid-e-Azam Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sadiq Abbasi Hospital, QAMC, Bahawalpur | Recruiting | Bahawalpur | Punjab Province | 63100 | Pakistan |
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| ID | Term |
|---|---|
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
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| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| D015032 | Zinc |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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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.
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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.
| Probiotic lactobacillus rhamnosus GG | Drug | Oral Probiotic Lactobacillus rhamnosus GG drops daily as adjuvant to phototherapy. |
|
|
| D012816 | Signs and Symptoms |
| D007287 |
| Inorganic Chemicals |
| D017967 | Zinc Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |