A Phase 4 interventional study of IgM rich Immunoglobin in Neonatal SEPSIS and Very Low Birth Weight Baby, sponsored by Sir Takhtasinhji General Hospital. Completed at 1 site in India. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Sir Takhtasinhji General Hospital · Phase 4, Interventional, and Treatment
Among 12 studies in Neonatal Sepsis with a site in India — 2 open to participants now, 2 under way, 2 of them phase 3. Neonatal Sepsis · India.
Among the 12 studies in Neonatal Sepsis with a site in India, this one is the 9th largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2018, is the only one in phase 4, and was the 6th registered.
192 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.
Browse Neonatal Sepsis studies →2 of the 12 studies in Neonatal Sepsis with a site in India are open now. Recruiting first, the newest first:
Indian Council of Medical Research · Sites in India
Post Graduate Institute of Medical Education and Research, Chandigarh · Sites in India
A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →
Of the 23 Neonatal Sepsis studies recruiting now, 8 (35%) set no upper age limit and 15 (65%) stop at 75 or younger; 20 take children under 18; 2 take healthy volunteers.
This study: 1 Day to 30 Days · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 5 · Phase 4 1
First in 2004; this study’s year is marked. 2 started in 2018.
This study's enrollment of 60 is below the median of 181 across 102 interventional studies indexed under Neonatal Sepsis.
Median enrollment 250 across the 11 interventional studies, 3,202 across the 1 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 12 has an industry lead sponsor. The 10 most frequent:
Sir Takhtasinhji General Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
Sir Takhtasinhji General Hospital has 1 study filed under Neonatal Sepsis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Neonatal Sepsis with a site in India, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days.
Drug: IgM rich Immunoglobin
antibiotics only
Drug: IgM rich Immunoglobin
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
Also known as: Pentaglobin®
Discharge rates
patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics.
Time frame: 6 months
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.
Time frame: 6 months
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2018, 5 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pentaglobulin
Sir Takhtasinhji General Hospital