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

Not Applicable

Completed

• Conditions: Serum Bilirubin
• Interventions: Drug: Zinc sulfate; Other: Placebo; Other: Phototherapy

• Registration Number: NCT05161611
• Lead Sponsor: Makassed General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-06
• Study Start: 2021-12-17
• Study First Posted: 2021-12-17
• Status Verified: 2022-08
• Primary Completion: 2022-08-28
• Study Completion: 2022-08-28
• Last Update Submitted: 2022-08-28
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc sulfate	Phototherapy	Patients will receive 10mg/day zinc sulfate along with phototherapy after being diagnosed to have hyperbilirubinemia
Zinc sulfate	Zinc sulfate	Patients will receive 10mg/day zinc sulfate along with phototherapy after being diagnosed to have hyperbilirubinemia
Placebo	Placebo	Patients will receive placebo in addition to phototherapy
Placebo	Phototherapy	Patients will receive placebo in addition to phototherapy

Primary Outcome Measures

Name	Time	Method
Phototherapy duration	Within one week	The number of days the neonates required phototherapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon