Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit

Study Overview
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Brief Summary
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A randomized double-blind clinical trial will be performed in the neonatal intensive care unit of Makassed General Hospital in Beirut, Lebanon from December 2021 till August 2022. Randomized opaque envelopes to allocate the treatment will be used. The study will include neonates aged between 26 and 42 gestational weeks, who require phototherapy in the neonatal intensive care unit. Patients will be randomized into two groups.Both groups will receive standard conventional phototherapy, but the intervention group will receive 10 mg per day oral zinc sulfate until discharge.

Official Title
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The Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit: A Randomized, Double-Blind, Clinical Trial

Conditions
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Serum Bilirubin

Intervention / Treatment
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* Drug: Zinc sulfate
* Other: Placebo
* Other: Phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants (post-menstrual age ≥ 26 weeks) delivered by Cesarean section or vaginal delivery. Diagnosed to have hyperbilirubinemia: Hyperbilirubinemia is defined as: for term and near-term neonates (neonates less than 35 weeks' gestation): Serum Total Bilirubin (STB) level that would qualify for phototherapy requirement as described in American Academy of Pediatrics 2004's guidelines or absolute STB level L 15 mg/dL; for preterm neonates (< 35 weeks' gestation): STB level > 1% of body weight Exclusion Criteria: Infants less than 26 weeks postmenstrual age Allergy to zinc sulfate Any reaction seen after administration of first dose of zinc sulfate. Any contraindication to oral medication Infants with a history of taking phenobarbital by their mother

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc sulfate<br>Patients will receive 10mg/day zinc sulfate along with phototherapy after being diagnosed to have hyperbilirubinemia | Drug: Zinc sulfate<br>* 10 mg of oral zinc sulfate will be given to neonates per day<br>Other: Phototherapy<br>* Neonates will be put under phototherapy<br>|
| Placebo Comparator: Placebo<br>Patients will receive placebo in addition to phototherapy | Other: Placebo<br>* 10 mg of normal saline will be given to neonates per day<br>Other: Phototherapy<br>* Neonates will be put under phototherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phototherapy duration | The number of days the neonates required phototherapy | Within one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total serum bilirubin level | Level of total serum bilirubin will be measured in neonates | Within one week | 
| Occurrence of side effects | The incidence of side effects such as vomiting, diarrhea, or rash will be recorded | Within one week |