Effects of Probiotics on Neonatal Hyperbilirubinemia
Primary Purpose
Neonatal Hyperbilirubinemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Maflor®, Mamsel Pharmaceuticals, Turkey
drops of saline
Sponsored by
About this trial
This is an interventional prevention trial for Neonatal Hyperbilirubinemia focused on measuring Probiotic, Neonatal Hyperbilirubinemia
Eligibility Criteria
Inclusion Criteria:
- A total of 150 full-term (gestational age ≥37 - <42 weeks) normal spontaneous vaginal delivery healthy newborns
- Birth weight between the 10th-90th percentiles
- Fed by breast milk only
Exclusion Criteria:
- Newborns with familial hematologic disorders
- Having signs of hemolysis due to blood group incompatibilities
- Bleeding into closed spaces due to birth trauma complications (e.g. cephalohematoma)
- Suspected or documented neonatal infection such as chorioamnionitis, intrauterine infection, sepsis and urinary tract infection
- Perinatal and neonatal hypoxia
- Having thyroid dysfunction, respiratory distress or insufficiency, metabolic and thermoregulatory dysfunction, hemodynamic instability and congenital heart disease
- Maternal phenobarbital usage history during the last month of the pregnancy
- Having venous hematocrit (Htc) levels≥65%
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Probiotic
Saline
Arm Description
Experimental: Breast milk+ Probiotics(Maflor®, Mamsel Pharmaceuticals, Turkey) The study group will be fed with probiotics at a dose of 1x109 CFU/day (Lactobacillus rhamnosus GG 109colony ). Probiotic is in a liquid drop form at a dose of 5 drops a day and is used orally for 10 days.
Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics
Outcomes
Primary Outcome Measures
Effect of Probiotic Support on Serum Bilirubin Levels
The effect of probiotic support on serum bilirubin levels during the first 10 days were measured and results were given as mg/dL.
Secondary Outcome Measures
Defecation frequency
Number of defecation frequency releated to treatment was evaluated and counted as times/a day.
Full Information
NCT ID
NCT02807246
First Posted
June 8, 2016
Last Updated
June 16, 2016
Sponsor
Karadeniz Technical University
1. Study Identification
Unique Protocol Identification Number
NCT02807246
Brief Title
Effects of Probiotics on Neonatal Hyperbilirubinemia
Official Title
Effects of Probiotics on Neonatal Hyperbilirubinemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karadeniz Technical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was designed as a prospective controlled study to investigate the effects of probiotic support started immediately after birth on newborn jaundice in breastfed babies born by normal spontaneous vaginal delivery.
Detailed Description
Objectives: Enterohepatic circulation of bilirubin imposes an extra burden of approximately 30% on total serum bilirubin levels. Intestinal microflora is the main factor affecting enterohepatic circulation. This study investigated the effects of probiotic support started immediately after birth on neonatal hyperbilirubinemia in babies born by normal spontaneous vaginal delivery and breastfed only.
Methods: A total of 150 healthy term newborns were included in the study and allocated in the study and control groups. Immediately after birth, newborns in the study group received probiotic in liquid drop form (Maflor® drops containing Lactobacillus Rhamnosus GG 109 Colony Forming Units(CFU), Mamsel Pharmaceuticals, Turkey), at a dose of 5 drops a day orally for 10 days. Newborns in the control group received 5 drops of saline solution per day orally, instead. In addition to routine biochemical examinations;serum bilirubin levels in the cord blood, and blood samples of the newborns on the 3rd, 5th and 10th days of birth were measured in all subjects in both groups. Defecation frequency was recorded for all subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hyperbilirubinemia
Keywords
Probiotic, Neonatal Hyperbilirubinemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Experimental: Breast milk+ Probiotics(Maflor®, Mamsel Pharmaceuticals, Turkey) The study group will be fed with probiotics at a dose of 1x109 CFU/day (Lactobacillus rhamnosus GG 109colony ). Probiotic is in a liquid drop form at a dose of 5 drops a day and is used orally for 10 days.
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics
Intervention Type
Biological
Intervention Name(s)
Maflor®, Mamsel Pharmaceuticals, Turkey
Intervention Description
Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey)
Other Name: Maflor®
Intervention Type
Other
Intervention Name(s)
drops of saline
Intervention Description
Dietary Supplement: Breast milk +drops of saline
Primary Outcome Measure Information:
Title
Effect of Probiotic Support on Serum Bilirubin Levels
Description
The effect of probiotic support on serum bilirubin levels during the first 10 days were measured and results were given as mg/dL.
Time Frame
Change from birth to ten days of life
Secondary Outcome Measure Information:
Title
Defecation frequency
Description
Number of defecation frequency releated to treatment was evaluated and counted as times/a day.
Time Frame
Change from birth to ten days of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A total of 150 full-term (gestational age ≥37 - <42 weeks) normal spontaneous vaginal delivery healthy newborns
Birth weight between the 10th-90th percentiles
Fed by breast milk only
Exclusion Criteria:
Newborns with familial hematologic disorders
Having signs of hemolysis due to blood group incompatibilities
Bleeding into closed spaces due to birth trauma complications (e.g. cephalohematoma)
Suspected or documented neonatal infection such as chorioamnionitis, intrauterine infection, sepsis and urinary tract infection
Perinatal and neonatal hypoxia
Having thyroid dysfunction, respiratory distress or insufficiency, metabolic and thermoregulatory dysfunction, hemodynamic instability and congenital heart disease
Maternal phenobarbital usage history during the last month of the pregnancy
Having venous hematocrit (Htc) levels≥65%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yakup Aslan
Organizational Affiliation
Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Probiotics on Neonatal Hyperbilirubinemia
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