Hyperbilirubinemia, NeonatalPhase 3NCT03266913
Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia
A Phase 3 study testing Probiotic in people with Hyperbilirubinemia, Neonatal, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 2 to 28 days
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2017to 1 Nov 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 2 and 28 days old
- Having jaundice
- Gestational age between 35-42 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Children hospital
Bandar Abbas, Hormozgan, 763
Rakhshaneh Goodarzi, +989123004060, rakhshanehgoodarzi@yahoo.com
About this study
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.
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- Probiotic
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDrug
Also called PediLact
Probiotics drop
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily Receives: Drug: Probiotic |
| No probiotic | No intervention | Routine phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of phototherapy
Duration of phototherapy
Measured: 6 days
Secondary outcomes (1)
Discharge rate
percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Aug 2017
- Primary completion1 Oct 2017 (estimated)
- Study completion1 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Mahboobi, Hormozgan University of Medical Sciences
- Investigators
- Rakhshaneh Goodarzi, M.D, Principal investigator, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266913
- Sponsor's protocol ID
- 4889
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT03266913
- Acronym / sponsor ID
- 4889
- Conditions
- Hyperbilirubinemia, Neonatal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 1 Nov 2017 (estimated)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Drug: ProbioticRoutine phototherapy plus probiotic oral drops at the dose of 10 drops daily |
| No probiotic | No intervention | –Routine phototherapy |
Who may qualify
- Ages
- 2 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 2 and 28 days old
- Having jaundice
- Gestational age between 35-42 weeks
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: PediLactProbiotics drop | Drug | Probiotic |
Primary outcome
Duration of phototherapy
Time frame: 6 days
Duration of phototherapy
1 secondary outcome
Discharge rate
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
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Newborn Abdominal Massage to Prevent Hyperbilirubinemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakhshaneh Goodarzi, M.D principal investigator
Hormozgan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic in people with Hyperbilirubinemia, Neonatal, run by Hormozgan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rakhshaneh Goodarzi, M.D (+989123004060, rakhshanehgoodarzi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of phototherapy (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.