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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has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.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

In context

Hyperbilirubinemia, Neonatal

96 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.

This study's planned enrollment of 126 is above the median of 100 across 61 interventional studies indexed under Hyperbilirubinemia, Neonatal.

Browse Hyperbilirubinemia, Neonatal studies →

Lead sponsor

Hormozgan University of Medical Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 of 1 sites recruiting
  • Children hospital
    Bandar Abbas, Hormozgan 763, Iran, Islamic Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2017 (actual). Primary completion is estimated for Oct 2017, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2017
First posted
Aug 30, 2017
StartActual
Aug 1, 2017
Primary completionEst.
Oct 1, 2017
CompletionEst.
Nov 1, 2017
Last update
Aug 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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Studies of the drug tested here: Probiotic

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