Neonatal Hyperbilirubinemia
Conditions
Keywords
Probiotic, Neonatal Hyperbilirubinemia
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.
Interventions
BIOLOGICALMaflor®, Mamsel Pharmaceuticals, Turkey
Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey) Other Name: Maflor®
OTHERdrops of saline
Dietary Supplement: Breast milk +drops of saline
Sponsors
Karadeniz Technical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 10 Days
Healthy volunteers
Yes
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Probiotic Support on Serum Bilirubin Levels | Change from birth to ten days of life | The effect of probiotic support on serum bilirubin levels during the first 10 days were measured and results were given as mg/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Defecation frequency | Change from birth to ten days of life | Number of defecation frequency releated to treatment was evaluated and counted as times/a day. |
Outcome results
None listed