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Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03266913
Enrollment
126
Registered
2017-08-30
Start date
2017-08-01
Completion date
2017-11-01
Last updated
2017-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia, Neonatal

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.

Interventions

DRUGProbiotic

Probiotics drop

Sponsors

Hormozgan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Days to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of phototherapy6 daysDuration of phototherapy

Secondary

MeasureTime frameDescription
Discharge rate6 dayspercentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission

Countries

Iran

Contacts

Primary ContactRakhshaneh Goodarzi, M.D
rakhshanehgoodarzi@yahoo.com+989123004060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026