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

August 28, 2022 updated by: Mariam Rajab, Makassed General Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Makassed General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makassed General Hospital

Investigators

  • Principal Investigator: Mariam Rajab, MD, Makassed General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2021

Primary Completion (Actual)

August 28, 2022

Study Completion (Actual)

August 28, 2022

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 28, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22062021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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