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

Primary Purpose

Serum Bilirubin

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Zinc sulfate
Placebo
Phototherapy
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Serum Bilirubin

Eligibility Criteria

1 Hour - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Makassed General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zinc sulfate

Placebo

Arm Description

Patients will receive 10mg/day zinc sulfate along with phototherapy after being diagnosed to have hyperbilirubinemia

Patients will receive placebo in addition to phototherapy

Outcomes

Primary Outcome Measures

Phototherapy duration
The number of days the neonates required phototherapy

Secondary Outcome Measures

Total serum bilirubin level
Level of total serum bilirubin will be measured in neonates
Occurrence of side effects
The incidence of side effects such as vomiting, diarrhea, or rash will be recorded

Full Information

First Posted
December 6, 2021
Last Updated
August 28, 2022
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05161611
Brief Title
Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit
Official Title
The Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit: A Randomized, Double-Blind, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
August 28, 2022 (Actual)
Study Completion Date
August 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serum Bilirubin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc sulfate
Arm Type
Experimental
Arm Description
Patients will receive 10mg/day zinc sulfate along with phototherapy after being diagnosed to have hyperbilirubinemia
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo in addition to phototherapy
Intervention Type
Drug
Intervention Name(s)
Zinc sulfate
Intervention Description
10 mg of oral zinc sulfate will be given to neonates per day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
10 mg of normal saline will be given to neonates per day
Intervention Type
Other
Intervention Name(s)
Phototherapy
Intervention Description
Neonates will be put under phototherapy
Primary Outcome Measure Information:
Title
Phototherapy duration
Description
The number of days the neonates required phototherapy
Time Frame
Within one week
Secondary Outcome Measure Information:
Title
Total serum bilirubin level
Description
Level of total serum bilirubin will be measured in neonates
Time Frame
Within one week
Title
Occurrence of side effects
Description
The incidence of side effects such as vomiting, diarrhea, or rash will be recorded
Time Frame
Within one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Rajab, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

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

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