Neonatal SepsisPhase 3NCT02954926
Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
A Phase 3 study testing IVIG in people with Neonatal Sepsis, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
Majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Neonatal Sepsis
- What is being tested?
- IVIG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIran
- Study dates
- Nov 2015to Nov 2016
- 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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born alive before 37 weeks of pregnancy (preterm neonates)
- Under 2500 g at birth
Who cannot join
- lethal anomaly
- congenital heart disease
- TORCH infection
- severe asphyxia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
Majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis. The objective of this research is to determine the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis.
- Conditions
- Neonatal Sepsis
- Being tested
- IVIG
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGDrug
IVIG at a dose of 500mg/kg within 12 h and 3 days of birth
| Study group | Role | What they receive |
|---|---|---|
| IVIG | Experimental | IVIG at a dose of 500mg/kg within 12 h and 3 days of birth Receives: Drug: IVIG |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death from sepsis or its related complications
Measured: 7 days
Secondary outcomes (4)
Total number of days of hospitalization
Duration of hospitalization
Measured: 7 days
Intraventricular Hemorrhage
occurrence of Intraventricular Hemorrhage
Measured: 7 days
Necrotizing enterocolitis
occurrence of Necrotizing enterocolitis
Measured: 7 days
Bronchopulmonary dysplasia
occurrence of Bronchopulmonary dysplasia
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954926
- Sponsor's protocol ID
- HUMS.REC.1394.162
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2016
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT02954926
- Acronym / sponsor ID
- HUMS.REC.1394.162
- Conditions
- Neonatal Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Nov 2016 (estimated)
- 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.
Majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis. The objective of this research is to determine the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG | Experimental | Drug: IVIGIVIG at a dose of 500mg/kg within 12 h and 3 days of birth |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Born alive before 37 weeks of pregnancy (preterm neonates)
- Under 2500 g at birth
Key exclusion criteria (4 listed)
- lethal anomaly
- congenital heart disease
- TORCH infection
- severe asphyxia
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 |
|---|---|---|
| IVIGIVIG at a dose of 500mg/kg within 12 h and 3 days of birth | Drug | IVIG |
Primary outcome
Mortality
Time frame: 7 days
Death from sepsis or its related complications
4 secondary outcomes
Total number of days of hospitalization
Time frame: 7 days
Intraventricular Hemorrhage
Time frame: 7 days
Necrotizing enterocolitis
Time frame: 7 days
Bronchopulmonary dysplasia
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 IVIG in people with Neonatal Sepsis, 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 2 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: finished, as of the sponsor's last update on 4 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 7 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 4 Nov 2016.