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Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset sepsis.
Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days)
Short duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics
Standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short duration antibiotic | Experimental | antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment |
|
| Standard duration antibiotic | Active Comparator | Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short duration antibiotics | Other | antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of 'Treatment Failure' | New onset appearance of clinical signs and symptoms requiring initiation of antibiotics | 15 days of stopping antibiotics |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death due to any reason | Till 1 month of life |
| Need for additional courses of antibiotic therapy | Additional courses during the study time frame |
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Inclusion Criteria (All must be present)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lady Hardinge Medical college | New Delhi | National Capital Territory of Delhi | 110001 | India |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Standard duration antibiotics | Other | Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment. |
|
| Till 1 month of life |
| Length of hospital stay | Duration of hospital stay | From date of birth until date of death or discharge whichever come assessed till 1 month of life |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |