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

NCT ID: NCT05161611

Last Updated: 2022-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2022-08-28

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.

Conditions

Serum Bilirubin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Zinc sulfate

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

Group Type: EXPERIMENTAL

Zinc sulfate

Intervention Type: DRUG

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

Phototherapy

Intervention Type: OTHER

Neonates will be put under phototherapy

Placebo

Patients will receive placebo in addition to phototherapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Phototherapy

Intervention Type: OTHER

Neonates will be put under phototherapy

Interventions

Zinc sulfate

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Phototherapy

Neonates will be put under phototherapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makassed General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mariam Rajab

Chairperson of Pediatrics Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariam Rajab, MD

Role: PRINCIPAL_INVESTIGATOR

Makassed General Hospital

Locations

Makassed General Hospital

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

22062021

Identifier Type: -

Identifier Source: org_study_id