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

  • STATUS
    Recruiting
  • days left to enroll
    57
  • participants needed
    60
  • sponsor
    Makassed General Hospital
Updated on 26 December 2021

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.

Details
Condition Serum Bilirubin
Treatment Placebo, Phototherapy, Zinc Sulfate
Clinical Study IdentifierNCT05161611
SponsorMakassed General Hospital
Last Modified on26 December 2021

Eligibility

Yes No Not Sure

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
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