Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia
1 other identifier
interventional
126
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedAugust 30, 2017
August 1, 2017
2 months
August 28, 2017
August 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of phototherapy
Duration of phototherapy
6 days
Secondary Outcomes (1)
Discharge rate
6 days
Study Arms (2)
Probiotic
ACTIVE COMPARATORRoutine phototherapy plus probiotic oral drops at the dose of 10 drops daily
No probiotic
NO INTERVENTIONRoutine phototherapy
Interventions
Eligibility Criteria
You may qualify if:
- Between 2 and 28 days old
- Having jaundice
- Gestational age between 35-42 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children hospital
Bandar Abbas, Hormozgan, 763, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rakhshaneh Goodarzi, M.D
Hormozgan University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 28, 2017
First Posted
August 30, 2017
Study Start
August 1, 2017
Primary Completion
October 1, 2017
Study Completion
November 1, 2017
Last Updated
August 30, 2017
Record last verified: 2017-08