Sepsis of the NewbornPhase 4NCT01006499
Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
A Phase 4 study testing Pentoxifylline, pentaglobin in people with Sepsis of the Newborn, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis. Read more about this study
- Who is it for?
- Ages 1 day to 90 days
- Conditions the study is for
- Sepsis of the Newborn
- What is being tested?
- Pentoxifylline, pentaglobin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 4
- 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 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All infants thought/diagnosed to have late or early onset sepsis.
Who cannot join
- Pentoxifylline or Pentaglobin has already been given
- Pentoxifylline or Pentaglobin is thought to be needed or contra-indicated
- Major congenital anomaly
- Intraventricular hemorrhage (Grade 3 veya 4)
- Congenital infections
- Inborn errors of metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.
- Conditions
- Sepsis of the Newborn
- Being tested
- Pentoxifylline, pentaglobin
- Keywords
- neonatal sepsis, pentoxyfilline, pentaglobin, biomarker, To reduce mortality in neonatal sepsis
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline, pentaglobinDrug
Pentaglobin 250mg/kg/d over 4 hour for three days Pentoxyfilline 6mg/kg/h over 4 hour for three days Pentaglobin 250mg/kg/d over 4 hour for three days+Pentoxyfilline 6mg/kg/h over 4 hour for three days Placebo (normal saline 5ml/kg over 4 hour for three days
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours). Receives: Drug: Pentoxifylline, pentaglobin |
| Pentoxifylline group | Active comparator | Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days. Receives: Drug: Pentoxifylline, pentaglobin |
| Pentaglobin group | Active comparator | Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days Receives: Drug: Pentoxifylline, pentaglobin |
| Pentoxifylline plus Pentaglobin group | Active comparator | Standard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days. Receives: Drug: Pentoxifylline, pentaglobin |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient characteristics all cause mortality
Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis
Measured: two years
Secondary outcomes (2)
Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels
Assess the effectiveness of Pentoxifylline or Pentoxifylline plus IgM enriched IVIG in reducing neuro-developmental morbidity secondary to sepsis at the age of 18 months
Measured: two years
Effect the production of pro-inflammatory bio-markers.
Whether Pentoxifylline or Pentoxifylline plus IgM enriched IVIG reduces the production of pro-inflammatory bio-markers
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis of the NewbornStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006499
- Sponsor's protocol ID
- 1-akdag
- Status last verified
- Mar 2011
- First submitted
- 1 Nov 2009
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
- ClinicalTrials.gov ID
- NCT01006499
- Acronym / sponsor ID
- 1-akdag
- Conditions
- Sepsis of the Newborn
- Keywords
- neonatal sepsis, pentoxyfilline, pentaglobin, biomarker, To reduce mortality in neonatal sepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 Nov 2009 (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.
The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Pentoxifylline, pentaglobinReceiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours). |
| Pentoxifylline group | Active comparator | Drug: Pentoxifylline, pentaglobinStandard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days. |
| Pentaglobin group | Active comparator | Drug: Pentoxifylline, pentaglobinStandard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days |
| Pentoxifylline plus Pentaglobin group | Active comparator | Drug: Pentoxifylline, pentaglobinStandard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days. |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All infants thought/diagnosed to have late or early onset sepsis.
Key exclusion criteria (6 listed)
- Pentoxifylline or Pentaglobin has already been given
- Pentoxifylline or Pentaglobin is thought to be needed or contra-indicated
- Major congenital anomaly
- Intraventricular hemorrhage (Grade 3 veya 4)
- Congenital infections
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 |
|---|---|---|
| Pentoxifylline, pentaglobinPentaglobin 250mg/kg/d over 4 hour for three days Pentoxyfilline 6mg/kg/h over 4 hour for three days Pentaglobin 250mg/kg/d over 4 hour for three days+Pentoxyfilline 6mg/kg/h over 4 hour for three days Placebo (normal saline 5ml/kg over 4 hour for three days | Drug | Pentaglobin group, Pentoxifylline group, Pentoxifylline plus Pentaglobin group, Placebo group |
Primary outcome
patient characteristics all cause mortality
Time frame: two years
Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis
2 secondary outcomes
Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels
Time frame: two years
Effect the production of pro-inflammatory bio-markers.
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
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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 4 study testing Pentoxifylline, pentaglobin in people with Sepsis of the Newborn, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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 11 Mar 2011. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
patient characteristics all cause mortality (time frame: two years). 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 11 Mar 2011.