CTRI/2024/01/062023
Not yet recruiting
Not Applicable
To study the effect of probiotics preparation Infloran® supplementation in on morbidities in Indian preterm neonates (PrISM)
Dr Nandini Desai Principle1 site in 1 country200 target enrollmentStarted: February 25, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Nandini Desai Principle
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- suspected or confirmed positive Bell state II or more (1)(2)
Overview
Brief Summary
Preterm infants born at the study site hospitals or referred to these hospitals will be enrolled in the study, if they satisfy all inclusion criteria and meet none of the exclusion criteria.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Day(s) to 7.00 Day(s) (—)
Inclusion Criteria
- •Gestation: Preterm infants and neonates born at 32 weeks gestation or 32 to 36 weeks gestation Age at recruitment: within 7 days of age Weight: very low birth weight or lessthan 1500 grams Gender any.
Exclusion Criteria
- •Severe birth complications Malformation of the gut (omphalocele, gastroschisis, intestinal atresia) Chromosomal anomalies Neonates with central venous catheter Neonates on antifungal drugs.
Outcomes
Primary Outcomes
suspected or confirmed positive Bell state II or more (1)(2)
Time Frame: Day 42 after the birth
Secondary Outcomes
- Culture positive sepsis: blood culture positive(Clinical sepsis: clinical features of sepsis without positive blood culture)
- All-cause mortality(Day 42 after the birth)
Investigators
Dr Bhadresh R Vyas
M P Shah Medical College and G G Hospital, Jamnagar
Study Sites (1)
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