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临床试验/NCT06672406
NCT06672406已完成不适用

Effect of Probiotic Lacobacillus Reuterii on Serum Bilirubin Levels in Preterm Infants

Hasanuddin University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Total bilirubin level

研究概览

简要总结

The goal of this clinical trial is to learn about the effect of probiotic Lactobacillus reuterii on the level of serum bilirubin in moderately and late preterm infants with birth weights 1000 grams to 2499 grams who were admitted to the NICU at Dr. Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital and Cahaya Medika Hospital. The main questions it aims to answer are:

  • Are bilirubin levels in preterm infants who received probiotics were lower than those who did not receive probiotics?
  • Is the incidence of hyperbilirubinemia requiring phototherapy in preterm infants who received probiotics less than those who did not receive probiotics?

详细描述

This study aims to investigate the effect of probiotic Lactobacillus reuteri administration on serum bilirubin levels in preterm infants. It is a randomized controlled trial conducted at the Neonatal Intensive Care Units of Dr. Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital and Cahaya Medika Hospital in Makassar, South Sulawesi, Indonesia. The study population includes infants born at 32 to <37 weeks gestational age with birth weights between 1000-2499 grams who are admitted to the NICU. Eligible infants are randomized into two groups - an intervention group receiving probiotic L. reuteri (5 drops daily for 7 days) and a control group not receiving probiotics. The primary outcome is serum bilirubin levels, measured at baseline and after 7 days of intervention. Secondary outcomes include incidence of hyperbilirubinemia requiring phototherapy and changes in bilirubin levels in those receiving phototherapy. Blood samples are collected to measure total and direct bilirubin levels. The study aims to enroll 40 infants (20 per group) to detect a clinically meaningful difference in bilirubin levels between groups. This trial will provide evidence on whether probiotic supplementation with L. reuteri can reduce the severity of hyperbilirubinemia in preterm infants. The results may inform clinical practice regarding the use of probiotics as an adjunctive therapy for neonatal jaundice in this vulnerable population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The preterm infant subjects and their parents were blinded to whether they received the probiotic intervention or were in the control group.

入排标准

年龄范围
— 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Premature Infants (32 - < 37 weeks gestation)
  • Birth weight 1000 - 2499 grams
  • Sick infants who are treated in the NICU
  • Preterm infants who received enteral feeding > 30 cc/kgBB less than 72 hours after birth, without jaundice or jaundice Kremer 1,2, and 3
  • Parents have signed their child's consent to participate in the study

排除标准

  • Infants with multiple congenital abnormalities
  • Infants with jaundice before 24 hours or having jaundice cremer > 4 less than 72 hours from birth
  • Infants with Sepsis, Metabolic acidosis

结局指标

主要结局

Total bilirubin level

时间窗: Total bilirubin level was measured after 7th day of intervention

We compare the total bilirubin level between participants who received probiotics and those who did not receive probiotics

次要结局

未报告次要终点

研究者

发起方
Hasanuddin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurwahyuni Rachim

dr. Nurwahyuni Rachim

Hasanuddin University

研究点 (2)

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