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Completed

NCT Number: NCT06672406

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

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?

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Key information

Conditions

Hyperbilirubinemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lactobacillus reuterii

Dietary Supplement

Participants in the intervention group received probiotic Lactobacillus reuterii if they received enteral feeding > 30 cc/kgBW. 5 drops of probiotics were given for 7 days in the breast milk or formula milk that did not contain probiotics

Primary outcomes

  1. Total bilirubin level

    Time frame: 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

Other outcomes

  1. Phototherapy

    Time frame: The need for phototherapy was assessed throughout the intervention (7 days)

    We compare the number of participants who needed phototherapy between probiotic and non-probiotic group

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2024
Registry last updated
Nov 26, 2024

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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