Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03266913
• Other study ID #: 4889
• Status: Recruiting
• Phase: Phase 3
• First received: August 28, 2017
• Last updated: August 29, 2017
• Start date: August 1, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: August 2017
• Source: Hormozgan University of Medical Sciences
• Contact: Rakhshaneh Goodarzi, M.D
• Phone: +989123004060
• Email: rakhshanehgoodarzi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is transient, it is associated with high rate of readmission of patients in the first week of infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering the fact that there have been a lot of studies on probiotic role in management of necrotizing enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in infants hospitalized in children hospital in Bandar Abbas.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: November 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Between 2 and 28 days old

• Having jaundice

• Gestational age between 35-42 weeks

Exclusion Criteria:

• Less than 2 days or more than 28 days old

• Gestational age out of the range of 35-42 weeks

• Infants whose parents refused to cooperate

• Patients with sepsis and other comorbid conditions

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

Intervention

Drug:
• Probiotic
Probiotics drop

Locations

Country	Name	City	State
Iran, Islamic Republic of	Children hospital	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of phototherapy	Duration of phototherapy	6 days
Secondary	Discharge rate	percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission	6 days