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To study the effect of oral probiotics supplementation on illnesses in newborns born premature (before 36 weeks of gestation)

To study the effect of probiotics preparation Infloran® supplementation in on morbidities in Indian preterm neonates (PrISM) - PrISM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/062023
Enrollment
200
Registered
2024-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K553- Necrotizing enterocolitis

Interventions

Intervention1: Probiotic preparation Infloran®: containing probiotics including Lactobacillus Acidophilus 1.0000 billion CFU and Bifidobacterium Bifidum 1.0000 billion CFU in each capsule Study Durati

Sponsors

Dr Nandini Desai Principle
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Severe birth complications Malformation of the gut (omphalocele, gastroschisis, intestinal atresia) Chromosomal anomalies Neonates with central venous catheter Neonates on antifungal drugs

Design outcomes

Primary

MeasureTime frame
suspected or confirmed positive Bell state II or more (1)(2)Timepoint: Day 42 after the birth

Secondary

MeasureTime frame
All-cause mortalityTimepoint: Day 42 after the birth;Culture positive sepsis: blood culture positive Clinical sepsis: clinical features of sepsis without positive blood culture Timepoint: Day 42 after the birth

Countries

India

Contacts

Public ContactDr Bhadresh R Vyas

M P Shah Medical College and G G Hospital, Jamnagar

bhadreshrvyas@yahoo.co.uk9825096054

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026