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

Makassed General Hospital

Status: Completed

Conditions: Serum Bilirubin

Treatments: Drug: Zinc sulfate; Other: Phototherapy; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05161611

22062021

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 1 hour to 1 month old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Zinc sulfate

Experimental group

Description:

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

Treatment:

Other: Phototherapy

Drug: Zinc sulfate

Placebo

Placebo Comparator group

Description:

Patients will receive placebo in addition to phototherapy

Treatment:

Other: Placebo

Other: Phototherapy