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

Serum Bilirubin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161611
• Other study ID #: 22062021
• Status: Completed
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: August 28, 2022

Study information

• Verified date: August 2022
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 28, 2022
• Est. primary completion date: August 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Jaundice
• Serum Bilirubin

Intervention

Drug:
• Zinc sulfate
10 mg of oral zinc sulfate will be given to neonates per day

Other:
• Placebo
10 mg of normal saline will be given to neonates per day
• Phototherapy
Neonates will be put under phototherapy

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phototherapy duration	The number of days the neonates required phototherapy	Within one week
Secondary	Total serum bilirubin level	Level of total serum bilirubin will be measured in neonates	Within one week
Secondary	Occurrence of side effects	The incidence of side effects such as vomiting, diarrhea, or rash will be recorded	Within one week