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

Makassed General Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Serum Bilirubin

Interventions

Zinc sulfateDRUG

10 mg of oral zinc sulfate will be given to neonates per day

PlaceboOTHER

10 mg of normal saline will be given to neonates per day

PhototherapyOTHER

Neonates will be put under phototherapy

Eligibility

Sex: ALLMin age: 1 HourMax age: 1 Month

Medical Language ↔ Plain English

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

Locations (1)

Makassed General Hospital

Beirut, Lebanon

Outcomes

Primary Outcomes

Phototherapy duration

The number of days the neonates required phototherapy

Time frame: Within one week

Secondary Outcomes

Total serum bilirubin level

Level of total serum bilirubin will be measured in neonates

Time frame: Within one week

Occurrence of side effects

The incidence of side effects such as vomiting, diarrhea, or rash will be recorded

Time frame: Within one week

Data from ClinicalTrials.gov

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