The Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit: A Randomized, Double-Blind, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Phototherapy duration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Zinc sulfate
Patients will receive 10mg/day zinc sulfate along with phototherapy after being diagnosed to have hyperbilirubinemia
干预措施: Zinc sulfate (Drug)
Zinc sulfate
Patients will receive 10mg/day zinc sulfate along with phototherapy after being diagnosed to have hyperbilirubinemia
干预措施: Phototherapy (Other)
Placebo
Patients will receive placebo in addition to phototherapy
干预措施: Placebo (Other)
Placebo
Patients will receive placebo in addition to phototherapy
干预措施: Phototherapy (Other)
结局指标
主要结局
Phototherapy duration
时间窗: Within one week
The number of days the neonates required phototherapy
次要结局
- Total serum bilirubin level(Within one week)
- Occurrence of side effects(Within one week)
研究者
Mariam Rajab
Chairperson of Pediatrics Department
Makassed General Hospital