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

NCT05161611 | Completed

• 1 other identifier: 22062021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Phototherapy duration

  The number of days the neonates required phototherapy

  Within one week

Secondary Outcomes (2)

• Total serum bilirubin level

  Within one week

• Occurrence of side effects

  Within one week

Study Arms (2)

Zinc sulfate

EXPERIMENTAL

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

Drug: Zinc sulfate; Other: Phototherapy

Placebo

PLACEBO COMPARATOR

Patients will receive placebo in addition to phototherapy

Other: Placebo; Other: Phototherapy

Interventions

Zinc sulfate DRUG

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

Zinc sulfate

Placebo OTHER

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

Placebo

Phototherapy OTHER

Neonates will be put under phototherapy

Placebo; Zinc sulfate

Eligibility Criteria

• Age: 1 Hour - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Interventions

Zinc Sulfate; Phototherapy

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Therapeutics

Study Officials

• Mariam Rajab, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of Pediatrics Department

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 17, 2021
• Study Start: December 17, 2021
• Primary Completion: August 28, 2022
• Study Completion: August 28, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

LE (1)