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Completed

NCT Number: NCT05161611

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

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.

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Key information

Conditions

Serum Bilirubin

Age range

1 hour–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makassed General Hospital

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zinc sulfate

Drug

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

Placebo

Other

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

phototherapy

Other

Neonates will be put under phototherapy

Primary outcomes

  1. Phototherapy duration

    Time frame: Within one week

    The number of days the neonates required phototherapy

Secondary outcomes

  1. Total serum bilirubin level

    Time frame: Within one week

    Level of total serum bilirubin will be measured in neonates

  2. Occurrence of side effects

    Time frame: Within one week

    The incidence of side effects such as vomiting, diarrhea, or rash will be recorded

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

The Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit: A Randomized, Double-Blind, Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2021
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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