Effects of Probiotics on Neonatal Hyperbilirubinemia

NCT02807246 | Completed

• 1 other identifier: 2014/115 24237859-120
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Hyperbilirubinemia

Keywords

Probiotic; Neonatal Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from birth to ten days of life

Secondary Outcomes (1)

• Defecation frequency

  Change from birth to ten days of life

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

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.

Biological: Maflor®, Mamsel Pharmaceuticals, Turkey

Saline

ACTIVE COMPARATOR

Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics

Other: drops of saline

Interventions

Maflor®, Mamsel Pharmaceuticals, Turkey BIOLOGICAL

Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey) Other Name: Maflor®

Probiotic

drops of saline OTHER

Dietary Supplement: Breast milk +drops of saline

Saline

Eligibility Criteria

• Age: 1 Day - 10 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Karadeniz Technical University: lead

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yakup Aslan

  Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 21, 2016
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: June 21, 2016

Record last verified: 2016-06