Clinical trial NCT02807246: Effects of Probiotics on Neonatal Hyperbilirubinemia
Official title: Effects of Probiotics on Neonatal Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Hyperbilirubinemia
Keywords: Probiotic
Neonatal Hyperbilirubinemia
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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%

Primary outcomes:
measure: Effect of Probiotic Support on Serum Bilirubin Levels
timeFrame: Change from birth to ten days of life
Secondary outcomes:
measure: Defecation frequency
timeFrame: Change from birth to ten days of life
Other outcomes:
Locations:
Study officials:
affiliation: Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey
name: Yakup Aslan
role: STUDY_CHAIR
References: