Neonatal SEPSISPhase 4IgMNSNCT03403530
Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
A Phase 4 study testing IgM rich Immunoglobin in people with Neonatal SEPSIS and Very Low Birth Weight Baby, run by Sir Takhtasinhji General Hospital at 1 site in India.
Trial summary
Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Neonatal SEPSIS, Very Low Birth Weight Baby
- What is being tested?
- IgM rich Immunoglobin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jan 2018to 30 Sep 2018
- 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 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm
- Very low birth weight baby: birth weight 1-1.5 kg
- Both inside and outside delivered babies
- Gender: males and females
- Probable severe sepsis (septic score)
Who cannot join
- Extremely low birth weight babies: < 1 kg
- Babies >1.5 kg birth weight
- Babies born with congenital malformations
- Full term babies
- IUGR babies
- Child with no signs of sepsis
- HBsAg Positive
- HIV Positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Analyze the Efficacy of IgM Rich Immunoglobulin as an Adjunct to Antibiotics in the Treatment of Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results. The data will be analysed on the basis of blood culture results and outcome of the patients.
- Conditions
- Neonatal SEPSIS, Very Low Birth Weight Baby
- Being tested
- IgM rich Immunoglobin
- Keywords
- IgM, Immunoglobulin, Neonatal sepsis, very low birth weight preterm
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgM rich ImmunoglobinDrug
Also called Pentaglobin®
the 'IgM rich immunoglobn' is the normal human immunoglobin containing Human plasma protein 50mg/ml of which immunoglobin is atleast 95% Immunoglobin M (IgM) 6mg Immunoglobin A (IgA) 6mg Immunoglobin G (IgG) 38mg
| Study group | Role | What they receive |
|---|---|---|
| case group | Active comparator | 'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days. Receives: Drug: IgM rich Immunoglobin |
| control group | Placebo comparator | antibiotics only Receives: Drug: IgM rich Immunoglobin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge rates
patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics.
Measured: 6 months
Secondary outcomes (1)
Duration of hospital stay
patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start30 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Takhtasinhji General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sonal V Jindal, Sir Takhtasinhji General Hospital
- Investigators
- Jayendra R Gohil, MD, Principal investigator, SirTakhtasinhjiGH, Prof Pediatrics, Govt MC, Bhavnagar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403530
- Sponsor's protocol ID
- svjindal
- Acronym
- IgMNS
- Status last verified
- Jul 2020
- First submitted
- 1 Jan 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capasso L, Borrelli A, Cerullo J, Pisanti R, Figliuolo C, Izzo F, Paccone M, Ferrara T, Lama S, Raimondi F. Role of immunoglobulins in neonatal sepsis. Transl Med UniSa. 2014 Dec 19;11:28-33. eCollection 2015 Jan-Apr.
PubMed 25674546Haque KN, Zaidi MH, Bahakim H. IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis. Am J Dis Child. 1988 Dec;142(12):1293-6. doi: 10.1001/archpedi.1988.02150120047038.
PubMed 3195529
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Analyze the Efficacy of IgM Rich Immunoglobulin as an Adjunct to Antibiotics in the Treatment of Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
- ClinicalTrials.gov ID
- NCT03403530
- Acronym / sponsor ID
- IgMNS / svjindal
- Conditions
- Neonatal SEPSIS, Very Low Birth Weight Baby
- Keywords
- IgM, Immunoglobulin, Neonatal sepsis, very low birth weight preterm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sir Takhtasinhji General HospitalOther government
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 18 Jan 2018 (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.
Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results. The data will be analysed on the basis of blood culture results and outcome of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | Active comparator | Drug: IgM rich Immunoglobin'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days. |
| control group | Placebo comparator | Drug: IgM rich Immunoglobinantibiotics only |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm
- Very low birth weight baby: birth weight 1-1.5 kg
- Both inside and outside delivered babies
- Gender: males and females
- Probable severe sepsis (septic score)
Key exclusion criteria (8 listed)
- Extremely low birth weight babies: < 1 kg
- Babies >1.5 kg birth weight
- Babies born with congenital malformations
- Full term babies
- IUGR babies
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 |
|---|---|---|
| IgM rich ImmunoglobinAlso: Pentaglobin®the 'IgM rich immunoglobn' is the normal human immunoglobin containing Human plasma protein 50mg/ml of which immunoglobin is atleast 95% Immunoglobin M (IgM) 6mg Immunoglobin A (IgA) 6mg Immunoglobin G (IgG) 38mg | Drug | case group, control group |
Primary outcome
Discharge rates
Time frame: 6 months
patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics.
1 secondary outcome
Duration of hospital stay
Time frame: 6 months
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 7 Jul 2020.
- Results publication: PubMed 25674546Capasso L, Borrelli A, Cerullo J, Pisanti R, Figliuolo C, Izzo F, Paccone M, Ferrara T, Lama S, Raimondi F. Role of immunoglobulins in neonatal sepsis. Transl Med UniSa. 2014 Dec 19;11:28-33. eCollection 2015 Jan-Apr.
- Results publication: PubMed 3195529Haque KN, Zaidi MH, Bahakim H. IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis. Am J Dis Child. 1988 Dec;142(12):1293-6. doi: 10.1001/archpedi.1988.02150120047038.
- 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.
Jayendra R Gohil, MD principal investigator
SirTakhtasinhjiGH, Prof Pediatrics, Govt MC, Bhavnagar
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 IgM rich Immunoglobin in people with Neonatal SEPSIS and Very Low Birth Weight Baby, run by Sir Takhtasinhji General Hospital at 1 site in India.
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 5 inclusion and 8 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 7 Jul 2020. 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 India. 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?
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?
Discharge rates (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03403530, which also lists 2 linked publications.
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 7 Jul 2020.