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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Preterm infants who receive 5 drops of probiotic Lactobacillus reuteri for 7 days |
|
| Control Group | No Intervention | Preterm infants who receive standard care without probiotics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total bilirubin level | We compare the total bilirubin level between participants who received probiotics and those who did not receive probiotics | Total bilirubin level was measured after 7th day of intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Phototherapy | We compare the number of participants who needed phototherapy between probiotic and non-probiotic group | The need for phototherapy was assessed throughout the intervention (7 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nurwahyuni Rachim, MD | Hasanuddin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasanuddin University | Makassar | South Sulawesi | 90245 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24848255 | Background | Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. Sci Transl Med. 2014 May 21;6(237):237ra65. doi: 10.1126/scitranslmed.3008599. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2024 | Oct 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D006932 | Hyperbilirubinemia |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This randomized controlled trial aims to assess the effect of probiotic Lactobacillus reuteri on serum bilirubin levels in preterm infants. The study will be conducted at NICUs in Makassar, Indonesia, enrolling infants born at 32 to <37 weeks gestation with birth weights of 1000-2499 grams. Forty infants will be randomized to receive either L. reuteri probiotic (5 drops daily for 7 days) or no probiotic. The primary outcome is serum bilirubin levels measured at baseline and after 7 days. Secondary outcomes include incidence of hyperbilirubinemia requiring phototherapy and changes in bilirubin levels in those receiving phototherapy. Blood samples will be collected to measure total and direct bilirubin. This trial will provide evidence on whether L. reuteri supplementation can reduce hyperbilirubinemia severity in preterm infants, potentially informing clinical practice regarding probiotic use as an adjunctive therapy for neonatal jaundice in this vulnerable population.
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The preterm infant subjects and their parents were blinded to whether they received the probiotic intervention or were in the control group.
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