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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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
Hasanuddin University
Makassar, South Sulawesi, Indonesia
Total bilirubin level
We compare the total bilirubin level between participants who received probiotics and those who did not receive probiotics
Time frame: Total bilirubin level was measured after 7th day of intervention
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