A study to know the efficacy of adjuvant IgM in reducing mortality of very low birth weight newborns with sepsis
Not Applicable
- Conditions
- Health Condition 1: P369- Bacterial sepsis of newborn, unspecified
- Registration Number
- CTRI/2022/09/045566
- Lead Sponsor
- Dr Rinku Saini
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.All Very Low Birth Weight newborns (1-1.499 kg) with sepsis
2.Prior written informed consent signed by the legal guardian
Exclusion Criteria
1.Very Low Birth Weight new-borns with congenital anomalies & TORCH infections
2.Refusal for consent
3.Very low birth weight newborns <1 kg birth weight (ELBW ââ?¬â?? extremely low birth weight newborns)
4.Severely ill septic VLBW newborns (with shock and/or requiring mechanical ventilation).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All cause mortalityTimepoint: 1 month
- Secondary Outcome Measures
Name Time Method -Incidence of Intracranial haemorrhageTimepoint: 1 month;duration of hospital stayTimepoint: 1 month;Incidence of Bronchopulmonary dysplasiaTimepoint: 1 month;Incidence of Necrotizing enterocolitisTimepoint: 1 month