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Status unknownNCT03266913Updated Aug 30, 2017

Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

A Phase 3 interventional study of Probiotic in Hyperbilirubinemia, Neonatal, sponsored by Hormozgan University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 2 Days to 28 Days. Per ClinicalTrials.gov, last updated 2017-08-30.

Sponsored by Hormozgan University of Medical Sciences · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
2 Days to 28 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperbilirubinemia, Neonatal
03

Who can participate

Ages eligible
2 Days to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Between 2 and 28 days old
  • Having jaundice
  • Gestational age between 35-42 weeks

Exclusion criteria

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
126 participants (estimated)

Study arms

  • Active comparator
    Probiotic

    Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily

    Drug: Probiotic

  • No intervention
    No probiotic

    Routine phototherapy

Interventions

  • DrugProbiotic

    Probiotics drop

    Also known as: PediLact

05

What researchers measure

Primary outcomes

  1. Duration of phototherapy

    Duration of phototherapy

    Time frame: 6 days

Secondary outcomes

  1. Discharge rate

    percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission

    Time frame: 6 days

06

Study locations

1 of 1 sites recruiting
  • Children hospital
    Bandar Abbas, Hormozgan 763, Iran, Islamic Republic of
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03266913
Lead sponsor
Hormozgan University of Medical Sciences
Responsible party
Hamidreza Mahboobi (Principle Investigator, Hormozgan University of Medical Sciences) — Principal investigator
First posted
Aug 30, 2017
Start date
Aug 1, 2017
Primary completion
Oct 1, 2017 (estimated)
Completion
Nov 1, 2017 (estimated)
Last update
Aug 30, 2017

Study contacts

Rakhshaneh Goodarzi, M.D
Contact
rakhshanehgoodarzi@yahoo.com
+989123004060
Rakhshaneh Goodarzi, M.D
principal investigator · Hormozgan University of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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