Neonatal SEPSIS, Very Low Birth Weight Baby
Conditions
Keywords
IgM, Immunoglobulin, Neonatal sepsis, very low birth weight preterm
Brief 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. The data will be analysed on the basis of blood culture results and outcome of the patients.
Interventions
DRUGIgM 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
Sponsors
Sir Takhtasinhji General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discharge rates | 6 months | patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | 6 months | patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics. |
Countries
India
Outcome results
None listed